QA Validation Contracting – Walloon Brabant Provide QA support and oversight to validation and manufacturing activities according to validation and production procedures.
Your responsibilities ? Provide a compliance expertise in validation :
Review/Approve the validation documentation regarding the GMP requirements and the Vaccines procedures
Ensure that production practices are aligned with validation conclusion
Attend all project meetings as QA validation representative
Ensure timely escalation to Management of critical issues during validation
Contribute to the deviation process providing QA oversight and approving deviation for deviations related to validation activities and/or impact of manufacturing deviations to validation activities
Pro-actively identify potential quality and compliance risks and manage these risks through the risk register and quality plan process
Work in autonomy with supervision/coaching
To define the validation strategies through the change control process
To write and implement some validation documentation (Validation Plan, Validation Summary Report, Risk Assessment, Gap Analysis , Periodic review ….)
To ensure the correct application of the validation quality systems in the field and to define improvement plan as required
To support the production, QA and technical service teams in the implementation of the validation activities.
Your profile ?
Former relevant industrial experience related to the requested seniority in Validation and QA in a biopharmaceutical industry.
Knowledge of GMP / CFR / Eudralex …
Knowledge of different regulations and standards related to validation activities
Good interpersonal relationship skills
Good oral and written communication skills in French & English
Problem solving and achievement oriented
To be a good team player in order to succeed in each validation project and routine activities
To be able to use a risk-based approach for problem solving and prioritization of tasks
Sense of urgency
University degree (Biotechnology, Agronomy, Chemistry or Pharmacy)
Knowledge of company tools (e.g. SAP, documentum) is an asset.
English : good
French : fluent
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. Do you have any questions? You can contact Caroline, [email protected]
Ensure that business processes, equipment and computerized/automated/analytical systems are developed, qualified or validated in compliance with applicable internal requirements and external standards such as (GCLP, GCP and IS0 9001:2015)
Provide QA expertise and support to related stakeholders and teams
Work with interdisciplinary teams to ensure quality standards are met throughout the automation lifecycle and ensure “one voice quality”
Review and approve from a quality perspective, if appropriate, relevant documentation linked to GCLP/GCP and CSV activities
Support management of technical complex problems, evaluate potential impacts on quality and ensure that the critical topics are adequately and timely escalated to management in accordance with internal procedures
Review and approve deviations/CAPA, procedures and all documentation supporting business processes.
Who are you ?
At least 1-3 years of experience in Quality and CSV in Pharmaceutical or Biotech company
Experience in computerized systems validation and equipment qualification
Knowledge of compliance rules and recommendations for CSV area (21 CFR part 11, GAMP) and for Business in pharmaceutical industries (GCLP, GCP, GMP)
Knowledge of risk management principles and tools
Strong knowledge and expertise of quality systems, especially Deviation, Change Control, CAPA.
Good communication and presentation skills
Ability to manage stakeholders and build relationships transversally in a matrix environment
Good knowledge of English (read, spoken and written)
Ability to manage time and priorities
Analytical mindset
Comfortable with the use of IT and computerized system tools.
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.
Our partner is looking for a Analytical Methods Validation Physico to strengthen its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines.
What are your responsibilities?
Scientist for Andrew+ automation strategic intent both vaccines and pharma
Andrew+ POV
Client/Server solution
Validation guidelines
To plan and work with several department to deliver a proof of value and provide guidelines for automate and automation software validation
To build and track global timelines.
Organize and participate to core team and Steerco meetings.
To track and maintain project deliverables, timelines, and budget
To formulate the overall project success and calculate savings/gains.
Key Deliverables:
MSP Online project plan
Decks for core team and steering comities
Global savings/gains documents
URS and IQOQPQ validation documents
Analytical method Qualification/Validation protocol and reports
Statistical analysis
Who are you ?
Master’s degree, Sciences or equivalent acquired through experience
Experience in GMP QC testing
Computer skills in excel, word, outlook, PowerPoint and MS Project
Experience in statistics
Experience in Computer system validation methodology
Competences:
Knowledge of laboratory operations.
Tech background
Strong analytical skills to address challenges.
Excellent written and oral communication skills in English. Build trust.
Ability to work under pressure due to the requested flexibility and reactivity of the activities
Ability to work in project teams in a multidisciplinary environment.
Understanding of the requirements of GMP environment and Data Integrity and Computer System Validation.
What can you expect ?
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.
Brabant Wallon – contracting Life cycle & Change Control Specialist
What are your responsibilities?
Develop further the process to prepare content on change controls for communication to external partners.
Manage meetings with external stakeholders and present information to Quality, regulatory and technical collaborators
Organize the transfer of information on change controls between GSK and QA department from external partner
Collaborate with people located in MPU’s and abroad. Convince them vis-à-vis decisions, procedures or processes, while remaining diplomatic and maintaining motivation.
Be able to manage internally (between colleagues from different departments) as well as externally.
Efficient follow-up to respond to any questions and respect the timings of the projects.
Establish & track key performance indicators for each step of the process
Lead the design of or optimization of process
Follow the implementation of changes and ensure alignment with RA and external partners to minimize the impact on supply continuity.
Write local SOP with new process, and ensure training of all stakeholders (MPU, QA, QC, site conformance, RA, MSAT).
Be responsible for the change controls specific to GSK working for an external partner
Collaborate on punctual projects such as participation to taskforces, development of standards
Who are you ?
Experience (preferable 5 years) in the following would be considered an asset :
(Bio)pharma & cGMP
Quality
Project management
Technical lifecycle
Bilingual French/English (oral & written)
Proactive with ability to identify and follow up on gaps in process
Ability to work under pressure due to the requested flexibility and reactivity of the activities
Be able to manage short term issues with long term activities in parallel.
Ability to work in project teams in a multidisciplinary environment and a matrixial organization
Be able to lead and manage cross-functional projects
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.
About our client Our client is looking to strengthen their team within the Center of Excellence in Validation with the support of a Junior Validation Engineer.
Your responsibilities Within the center of excellence in validation at LMSAT the responsibilities will be:
Support the improvement program regarding filters and filtration management, participate in the documentation review, including validation plans, protocols, reports, and standard operating procedures (SOPs).
Perform gap assessment between different documents and between documents and practices in the field. Propose improvement and simplification following observations.
Using current procedure and state of the art knowledge, contribute to build educational materials on validation topics.
Collect data across different system to build a database related with validation activities.
For a given situation, use available data and statistical tools to calculate operational ranges and min or maximum values as needed.
Executing validation protocols for equipment, systems, and processes, documenting each step to provide a comprehensive record.
Collaborate closely with cross-functional teams, including Quality Assurance, Manufacturing, and Engineering, to ensure all activities are performed in accordance with current Good Manufacturing Practices (cGMP) and other relevant guidelines.
Stay updated with industry trends, regulatory updates, and technological advancements to contribute to the development of best practices and innovative validation methodologies within the pharmaceutical manufacturing.
Skills and knowledge requirements
You have a bachelor’s or master’s degree in science or equivalent by experience.
You have an experience with equipment and process validation in the pharmaceutical industry.
You have a good knowledge of GMP regulations.
You have a good knowledge of aseptic technologies and viral processes.
You like to work in a team and are quality oriented.
Our offer Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way. Are you interested in this position? We invite you to apply. Do you have any questions? Please contact Aylin Ugurlu at [email protected]
GMP compliance Our client Our client is looking for a profile in GMP Compliance to join its team. The QA Spare parts is part of the QA for Technical Services. They ensure the QA oversight of the spare parts warehouse.
Your responsibilities – Release spare parts to be used on GMP equipment throughout the company plant. – Contact the spare parts' supplier in case of further investigation to allow release of the spare parts. – Ensure on the floor presence and be the point of contact for the operational team. – Participate to the strategy definition of the spare parts management and release. – Ensure the correct application of the quality systems on the field and to define improvement plan as required. – Process the backlog in release, investigations, and archives. – Challenge the new spare parts creations. – Review the modification proposed by the technical teams (MO). – Quickly understand the regulatory requirements for the spare parts – Use a risk-based approach for problem solving and prioritization of tasks – Blow a quality and compliance mindset through the operational team – Develop and continuously improve expertise linked to spare parts – expert on the field, technical and regulatory watch over, linked with global and corporate expertise functions
Skills and knowledge requirements – University degree (Biotechnology, Agronomy, Chemistry or Pharmacy) – At least 5 years professional experience in pharmaceutical environment. – Very good interpersonal relationship skills – To be a good team player in order to success in each validation project. – Fluent in French, good oral and written communication skills in English – Problem solving and achievement oriented – Knowledge of GMP Regulated environment – Strong organizational skills
Our offer Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way. Are you interested in this position? We invite you to apply. Do you have any questions? Please contact Aylin Ugurlu at [email protected]
Purpose of the Mission Engineering is primarily concerned with the installation and application of developed solutions, the maintenance of facilities, infrastructure, and equipment as well as the connection of services (water, chemicals, gases). Any other aspect in engineering like plant design, industrial programming, etc… may be concerned.
Primary Tasks & Responsibilities • Individually or as part of a project team responsible for solution design and process layouts for electricity and instrumentation equipment including the following installations: instrumentation and machinery for power generation, power supply, electrical protection, small cabling, calibration and measuring devices, Telecom equipment (data, Wifi, Deadman) and electrical distribution MT (36-11kV) and BT (400-230V-48V-24V). • Responsible for the execution, coordination and follow-up of solution designs and technical matters related to Process Control to ensure construction, transformation, commissioning, and qualification of the solution meets agreed cost, timing, technology, and quality standards in line with the Global Technical Services standards. • Key activities include: o Define functional, technical, and quality requirements. o Realize process studies, P&ID’s and process layouts whilst considering the operating and EHS characteristics at all design steps. o Ensure preparation and update of the project qualification and coordinate qualification activities of the installations. o Ensure work inspections are issued in line with quality standards. o Ensure systems legal conformity. o Coordinate technicians during execution to secure contracts and connection of services (water, chemicals, gases) and electricity.
Experience, Knowledge & Soft Skill Requirements • Demonstrates deep knowledge in design and implementation of engineering projects. • Practical experience in project supervision and people management • Perform his/her work in a cGMP consistent manner. • Experience in the Pharmaceutical industry
Soft Skills: • Good communication skills • Good project management skills: organization, cost, time, schedule, contracting, procurement, qualification, validation, technologies.
Education, Methodology & Certification Requirements • Industrial or Civil Engineer.
Our offer Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way. Are you interested in this position? We invite you to apply. Do you have any questions? Please contact Aylin Ugurlu at [email protected]
