Conduct audits of Study Reports, Study Phase Reports, Study Plans and Study Plan Amendments to assure the applicable OECD guidelines, SOPs and the Analytical Methods have been adhered to and that reported results accurately reflect the raw data according to SOPs and associated controlled documents
Archive audit documentation per SOPs; e.g., issued audit reports, supporting documentation, QAS, additional documents as expected according to SOPs and associated controlled documents
Follow up with CAPA owners to manage actions to an on-time completion according to SOPs and associated controlled documents Issue Management
Contribute to investigations of non-compliance to areas of research and development operations which are within the scope of the Good Laboratory Practice (GLP) Compliance Program, the Good Clinical Practice (Laboratory) Guidelines (GCP Lab), and relevant Human Tissue regulations according to Policies and Procedures
When requested, facilitate discussions with internal stakeholders and SME network to develop appropriate action plans, decisions and ensure efficient actions are taken to ensure compliance to according to Policies and Procedures and OECD Principles. Inspection Readiness Support
Provide support during GLP/GCP inspections and investigations conducted by international and national authorities or business partners according to Policies and Procedures as requested Other Responsibilities
When requested, represent R&D and PV Quality at interdepartmental, project and study team meetings as an individual contributor
When requested, provide guidance to other members of the R&D and Pharmacovigilance Quality team.
Your profile:
Bachelor's degree in Sciences
Ability to drive collaboration and engagement across the stakeholder network, motivating others to achieve results
Skilled in influencing others within a global matrix organization and driving informed decision–making
Capable of prioritizing and focusing on critical issues using a risk-based approach
Manage quality and compliance issues with diligence, rigor, transparency and timeliness
Demonstrate strong analytical skills with experience in analyzing and synthesizing complex data
Fluency in French & English
Our offer: Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
Be the central QA point of contact for the organization for investigations/deviations/ out-of-specifications/ audit observations associated with the assigned vendors. Perform the QA review of deviation notifications, retrieve and collect supportive information from involved stakeholders (Vendor Team, GQL, CAS, Business) to allow assessment.
Manage the key performance indicators (metrics) for key operational QA activities and services associated with the vendors in the defined described tracking tools (Vendor QA KPI tracker, QuickScore) and track the vendor’s performance
Ensure all Quality agreements are in place and take ownership of agreements for the vendors. Maintain Quality Agreement with the vendors up to date and perform periodic reviews and update of the agreement in close collaboration with the product GQLs and the vendors.
When applicable, be sure that the Annual Product Stability Program is rolled-out and executed at the vendor in accordance with the Stability Program
Ensure the Product Quality Reviews (PQR) are completed by the vendors in a timely manner and as needed, are reviewed within the requested time period. Ensure that this review is documented and made available in the Controlled Documents System.
Participate as QA representative to the recurrent vendor meetings, present issues and resolutions, and drive vendor quality performance through these meetings
Quality Complaints: Be the contact person for the follow-up with vendors for the manufacturing investigation part. When applicable, ensure that initial receipt, logging of quality complaints into the Complaint System and provision of responses to the complainant are professionally coordinated and managed.
If needed work with the Vendor team and Global Quality Lead to determine the Root cause of issues which may lead to a Corporate Technical Review (CTR) meeting. Coordinate vendor quality related investigations
Participate on ad-hoc basis to the Product Change Control Committees for activities related to the vendors
Provide expert QA advice, support and management for technical operational QA and general QA matters associated with the vendors
Work closely with Corporate QA teams, Technical Operation Teams, Business stakeholders and Affiliates in an effective and efficient way
Cover the entire product life cycle from initial commercialization including Technology Transfer/Knowledge transfer, commercial (key raw materials to distribution), product improvements to phase out for the assigned vendors
Developer and owner of the QA plans and product resource and capacity overview for activities associated with the assigned vendors
Ensure all relevant documentation are provided to the vendors and implemented (Methods, Specs, Master Batch record)
Ensure review of relevant RA dossier section related to the assigned vendors
Have the overview of audit and HA inspections related to the vendors. Track and follow-up on Audit observation and CAPA plan implementation at the vendor.
Be the QA stakeholder for Vendor Risk management.
Manage and control quality documents related to the vendors in the Controlled Documents System
Support on customer audits and Health Authority inspections at the vendors, as needed
Receipt, coordinate review and authorize product reworks and repackaging.
Drive resolution for complex quality issues related to the vendors in scope including coaching other VQL’s on problem solving for complex issues. Be the point of contact for critical post-release vendor issues (supply chain, distribution, etc.). Challenge current practices for issue resolution and incorporate new perspectives into existing problems.
As required provide Operational QA support to vendors for process, equipment and facilities qualification and project support
Act as substitute for other Vendor Quality Leads in times of absenteeism (e.g. vacation, illness)
Work in accordance with HSE and Corporate policy requirements and drive personal training and development activities to meet the needs of the business and professional career development.
Acts as a coach for VQL’s with less experience.
Acts as a Best Practice ambassador, leads best practices steams and uses knowledge of internal/external business environment to improve existing process
Act as coach for the direct reports, perform personal development discussions and manage year-end evaluations and objectives setting (if applicable).
Oversee the VQL activities performed by the direct reports (if applicable).
Your profile:
Master's Degree in Sciences
Must be knowledgeable in several areas of the global pharmaceutical industry, including the interpretation and practical application of applicable regulations. Has good background knowledge of the pharmaceutical industry from a business and technical perspective.
Must be able to act in most circumstances without direct supervision and handle complex/difficult situations. Output from actions will most likely impact activities across several departments.
Possess good auditing capabilities and skills
Must have the ability to manage projects/ activities across global geographies within the area of expertise.
Be able to coach/train/mentor colleagues and deliver training within area of expertise and assist with the development of top talent.
Root cause and risk management/assessment skills Problem Solving (Describe the level of “self-starting” thinking required in the for recognizing, analyzing and solving problems)
Our offer: Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
Autonomously manage and execute daily laboratory activities related to method development, validation, and transfers.
Contribute to release and stability testing in relation to the project, as appropriate.
Prepare, review, and approve documentation (procedures, protocols, reports).
Analyze experimental results.
Verify data accuracy.
Present and discuss results in project team meetings.
Perform all activities in compliance with GMP/HSE rules and regulatory requirements for each development phase of the product.
Your Profile
Master’s or Bachelor’s degree in biochemistry or analytical chemistry.
Proven expertise, preferably in the biotech industry.
Strong, proven laboratory skills.
Good knowledge of protein chemistry and techniques for separating polymers in a protein matrix.
Practical experience and expertise in at least one of the following analytical techniques:
Chromatography (Size-exclusion, Reverse-phase, Affinity, Ion exchange, HILIC, or HIC).
Electrophoresis (Capillary: CGE, CzE, iCE, or MauriCE).
Expertise in analytical method development and validation.
Ability to work autonomously in day-to-day tasks.
Ability to author and review comprehensive and accurate procedures, protocols, and reports.
A good knowledge of GLP/GMP rules is a plus.
Good English skills (both written and oral) are recommended for reports and communication.
Ability to manage multiple priorities and prioritize effectively.
Strong interpersonal skills to communicate and maintain good working relationships within the team and with internal/external customers/partners.
Ability to work in a matrix and customer-oriented environment.
Our offer: Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
Primary packaging systems innovation and new products development management :
New primary packaging systems development management in line with the strategy, “Pipeline Devices & Delivery Systems” and technologic/scientific platforms objectives and according to established working processes.
Clinical medical devices design and assessment
Primary packaging systems life cycle & sustaining management :
Primary packaging systems sustaining and life cycle management coordination and support to all operation sites and CMO’s.
Competitors pharmaceuticals primary packaging systems benchmarking management :
Competitors primary packaging systems portfolio analyze & characterization.
Primary packaging materials, components and technology scouting and assessment according to defined priorities
Planning, implementation and documentation to maintain and set up the systems (processes, resources, equipment) of the organizational unit
Where applicable: maintenance of and responsibility for the SOP processes assigned to the unit and direct sub-processes thereof
The job holder informs his superior about significant changes and progress without delay on a regular basis and in emergencies.
Within the unit and/or projects the job holder ensures that the internal regulations and the national laws and ordinances concerning occupational safety, accident prevention, waste removal and disposal, and environmental protection are observed
In the planning, performance and documentation of his work within the unit the job holder ensures that the applicable internal rules (Standard Operating Instructions, SOP) and the applicable national and international laws, regulations and directives are observed
The job holder participates in the necessary training defined for his job, e.g. SOP training sessions, GMP training sessions, projects management, technical/scientific trainings, conferences, etc
Your profile:
Minimum of 5 years working in the pharmaceutical/biologics/medical primary packaging industry. Operational GMP or quality experience would be a distinct advantage
Practical understanding of ISO13485, 21CFR820, 21CFR210/211, 21CFR4, ISO14971, ICHQ9, MDR requirements, USP, Ph.Eur. and JP standards, Food-contact legislations
Knowledge of Good Manufacturing Practice (e.g. ISO 13485, 21 CFR820, Medical Device Directive) and evolving regulatory expectations in the field of primary packaging raw materials, components and systems
Pharmaceutical business experience and familiarity with competitive landscape of primary packaging development process, regulatory requirements
Experience in global projects, ideally with USA or EU operational, HS&E processes and procedures
Proven track record in project management / Project Management certification will be a distinct advantage
Fluency in French & English
Our offer: Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
Coordinate qualification and validation activities for cleaning equipment (e.g., washers, COP stations).
Manage change controls and deviations using the Viva system (internal training provided).
Support the qualification of new equipment and validation activities by coordinating with production and support teams (e.g., ensuring availability of materials and personnel).
Collaborate with a Process Engineer on Washer and COP/SOP-related activities.
Participate in the review of validation protocols, test sheets, and reports.
Conduct regular on-site follow-ups and coordinate with production and automation teams.
Provide support during layout activities and machine qualification for the summer shutdown.
Documentation Responsibilities
Write and manage operational procedures (SOPs).
Draft and follow up on change controls and deviations.
Write URS (User Requirement Specifications) and Design Verification (DV) documents.
Review and approve qualification documentation as needed.
Your Profile
3 to 7 years of experience in qualification/validation or production within the pharmaceutical industry, ideally in sterile manufacturing.
Strong knowledge of Good Manufacturing Practices (GMP).
Proven coordination skills and ability to track qualification activities.
Experience in deviation and change control management.
Basic understanding of CSV qualification and automation processes.
Experience with cleaning systems (CIP/SIP) and automation tools (e.g., AVEVA) is a plus.
Familiarity with layout planning, equipment installation, and project management tools (e.g., MS Project, Excel).
Project management skills using MS Project or Excel.
Fluent in French, with strong English writing skills.
Our offer: Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
QC LIMS Specialist Contracting – Brabant Wallon Your responsibilities:
Act as a liaison between the local team and the global team to integrate new developments and keep documentation and training up to date.
Update training matrices according to new methods and specifications.
Assist users in training on new methods and gather their requests and points of attention.
Participate in project meetings and document reviews, and challenge deadlines and training.
Maintain smooth communication between different services and teams.
Manage and rethink the team's document structure to make it more accessible to end users.
Support the drafting of deviations and CAPA depending on workload.
Your Profil
3 to 6 years of experience in a similar role.
Knowledge of LIMS systems (ideally LabWare).
Knowledge of Good Manufacturing Practices (GMP) in a laboratory setting.
Ability to work autonomously and take initiative.
Strong communication and project management skills.
Analytical mindset and ability to understand the impacts of changes.
Document management skills.
Previous experience with the LabWare LIMS system.
Knowledge of digitalization processes in laboratories.
Interest in technology and ability to navigate IT systems.
Ability to train and support users in adopting new methods.
Project management experience.
Our offer: Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
Package owner : Supplier management, equipment final design, execution and qualification, P&ID tracking, electrical schematics, project execution (planning, coordination,….).
Your profile:
Master’s degree
Minimum 5 years of experience within pharmaceutical companies and working with Engineering offices
Requires project management experience in pharma, knowledge of qualification, and equipment design.
Experience: Preferably in CAPEX projects within a commercial GMP facility.
Good Upstream and Downstream Process Technical expertise.
Good knowledge in automated system.
Good Knowledge of cGxP requirments.
Automation: Siemens PCS7 knowledge beneficial; the role involves verifying compliance with software requirements.
Our offer: Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
Our partner is looking for an In vivo Principal Scientist to join its teams. This international company is well known for its pharmaceutical products.
Your responsibilities?
Collaborate across project teams to establish scientific in vivo strategy and study plans for drug discovery projects.
Serve as the in vivo pharmacology lead for several drug discovery projects. Ensure that projects have all critical in vivo data to enable project stage dependent decisions.
Work within multi-functional teams to support target identification, validation within the drug discovery process.
Work across the in vivo team in a highly collaborative manner, sharing expertise and resources to meet study needs across In Vivo Pharmacology.
Design and conduct in vivo studies to evaluate and establish efficacy, PK/PD relationship, combination strategy, biomarker identification and analysis.
Develop and characterize new in vivo mouse models and techniques.
Ensure team members comply with all regulatory requirements and internal policies (Ethics, HSE).
Interpretation, presentation, and documentation of experiments as well as preparation of reports. Written and verbal presentations of results within a multidisciplinary team environment.
Contribute to relevant in vivo sections of study reports and regulatory documents e.g., IND filings, patent.
Networking: develop external network and manage external collaborations.
Your profile?
Degree: PhD or equivalent experience in a relevant scientific field
In vivo experience: Extensive hands-on experience with in vivo studies and associated experimental techniques
FELASA C certification
Team spirit: Strong ability to collaborate effectively within a team and work in a cooperative environment.
Language skills: Intermediate level or higher proficiency in English
Our offer?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply.
Our partner is looking for a Qualification & Validation Engineer to join its team. This international company is well-known for its pharmaceuticals.
These positions aim to ensure the qualification and validation of production equipment, primarily for solid dosage forms and packaging.
Your responsibilities?
Qualification and validation of production equipment and installations
Cleaning validation within the scope of technology transfers and pharmaceutical development
Participation in process qualification optimization and continuous improvement
Support for various expansion and production capacity optimization projects
Interaction with production, maintenance, and quality assurance teams
Your profile?
5 to 8 years of experience in qualification and validation within the pharmaceutical industry
Knowledge of GMP regulations and best qualification practices
Strong experience in cleaning validation is highly valued
Skills in the qualification of packaging, assembly, and serialization equipment
Autonomy and ability to collaborate across multiple departments
Intermediate English level required for document reading and international supplier management
Our offer? Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply.
Your responsibilities: Design and development Quality assurance:
Oversee Design & Development activities, from Inputs definition through Design Transfer (including Validation/Verification activities)
Review and approve relevant sections of the device design control documentation and/or Technical Documentation File as required
Review and approve protocols and reports for Verification & Validation studies, technology transfers, stability studies, etc…
Review and approve the company documentation. Ensure Design History File (DHF) is in place
Support Risk Management Activities related to devices. Ensure risk assessments are performed at appropriate stages of development/commercialization and for decision making on issues arising.
Ensure deliverables are issued in accordance with the D&D plan
Review and approve submissions and responses
Vendor quality management:
Accommodate design & technology transfer and ensure systems alignment between vendor and the company
Performing focused assessments/audits
Preparation and negotiation of Quality Agreements
Ensure systems alignment between vendor and the company
Facilitate quality improvement activities at vendors and the company systems
Support risk register for the vendor, and follow up on mitigation activities
Monitor and trend vendor performance
Authority to accept release or block release of Medical Devices
Oversee inspection plans at CMO and the company
Quality processes:
Facilitate investigations and resolution of issues relating to deviation and change management
Review and approve deviations
Lead/review critical investigations
Track CAPA events and closure
Oversee/track change controls
Provide expert advice and support on operational and general QA activities for projects part of the devices portfolio (Process improvement, Technology Transfers, New products or life-cycle management…):
Act as the Operational QA link between selected external vendors within the Medical Device portfolio
Assist with regulatory and customer inspections at Vendors. Specifically focus on: Inspection preparation, Support during inspection, Support post inspection observation closure
Work closely with staff in the Corporate QA teams (especially CM&C Clinical Supply QA, Corporate Compliance and Affiliate Quality Services) and key Technical Operations teams/Affiliate teams to ensure that all QA services for selected critical vendors are provided in an effective and efficient way
Work in accordance with HSE and Corporate policy requirements and drive personal training and development activities to meet the needs of the business and professional career development
Support additional projects as requested
Provide on-site presence ‘in plant’ or on site at vendor
General GMP:
Maintain Quality System elements associated with the ISO, MDR and GMP activities in a compliant manner
Drive/Support projects related to quality system improvement
Maintain key performance indicators (metrics) for key operational development QA activities and services associated with the Medical Devices and Combination Products activities
Maintain GMP compliance and inspection/audit readiness at all times. Support Medical Devices QA in the inspection/audit preparation activities, during inspection/audit and for closure of inspection/audit observation with associated CAPA commitments
Support Medical Devices and Combination Products related inspections
Support Management Review Process
Support Design Reviews
Your profile:
Master’s degree in Sciences
Minimum of 5 years working in the pharmaceutical/biologics/medical device industry in a quality management position. Operational GMP experience or clinical activities experience would be a distinct advantage.
Fluency in French and in English
Practical understanding of ISO 13485:2016, MDR, ISO 14971 and 21CFR820 and part 4 requirements.
US and EU knowledge of pharmaceutical and medical devices regulations together with quality principles and techniques.
Our offer: Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
