• Location: Mont-Saint-Guibert
• Type: Perm
• Job #17508

Our partner is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely, on time and wherever they are needed in the world.

Role

• Ensure the availability, the update and continuous improvement of the quality management system
• Lead the site Quality (Management) Review board
• Function as Quality department liaison and subject matter expert to other department representatives, QP’s/RP’s, customers, and regulatory representatives in relation to Supplier qualification, self-inspection, Agency inspections and customer audits
• Contribute to the quality department's activities to ensure continuity of operations
• Know, understand, and comply with the company’s standard operation procedures and policies
• Perform and contribute to qualification of suppliers and vendors
• As required, participate in the Quality Management System, including Change Controls, Non-conformances (including root cause investigations) and CAPA
• To participate in the self-inspection of the Quality System and to carry out independent audits of external vendors as required
• Support Client hosted audits and Competent Authority inspections, covering preparation, participation and follow-up/CAPA
• Train/coach/develop and evaluate direct reports and provide timely and compliant employee counselling as discipline and performance issues arise
• Identify and support the implementation of improvement opportunities, collaborating with the business areas, to form a strong and effective operational excellence team dynamic
• Maintain paper and electronic records for quality documentation
• Manage ad-hoc Quality projects

Requirements

• Pharmacist´s degree or equivalent degree in life science study, e.g., Veterinary or Biology
• Experience (10 years) in Quality Assurance or in an equivalent function (operations for instance)
• Experience in leading Quality audits/inspections-internal and external. Ideally as qualified auditor
• Experiences with clinical trials and IMP. Experienced in GMP and GDP, GCP is a plus
• Experience in working in a matrix organization
• Pragmatic
• People management
• Excellent communication and intercultural skills
• Resilience
• Ability to find compromises
• Team worker and team spirit
• Customer oriented
• High organizational and planning skills
• Work with accuracy and reliability
• Good dose of assertiveness
• Good computer skills: MS office, other office software
• Fluent in French and English. Any additional language is an asset

If you are interested, you can send your resume to Dimitri Soupart : [email protected]

• Location: Mont Saint Guibert
• Type: Perm
• Job #16628

ORGANISATION

Our partner is a global pharmaceutical and services company with a unique combination of businesses focused on providing access to medicines to improve the quality of people's lives around the world. We are the global leading experts, trusted by both pharmaceutical and biotech companies and healthcare professionals, in providing access to medicines throughout the lifecycle of a medicine; clinical trials, unlicensed and commercial supply.

We are currently 1000+ people, headquartered in the UK, with global offices in the US, Asia Pacific, South Africa, and across Europe. Our mission is to deliver the right medicine to the right patient at the right time and to help achieve this, we’re always on the lookout for motivated, ambitious and committed individuals to join our highly successful team.

ROLE

This position is responsible for enabling CCSM to achieve best-in-class quality by taking the lead in Incident/Investigation and CAPA preparation while meeting scheduled timelines. This position partners with all functional area leaders and is result-focused by improving our Investigation/CAPA process.

• Support both Operations and Quality by writing and ensuring effective implementation of CCSMs Incident Reports, Investigations, Corrective and Preventative Actions documents
• Interview Subject Matter Experts (SMEs) and involved employee(s) investigating reported problems and assess the quality impact
• Schedule investigational meeting(s) with the required team members(s)
• Use problem solving techniques to identify root cause analysis, and develop strategic solutions based on employee interviews of each incident
• Assist Operations in standard operating procedure development as needed
• Document review and report generation as required
• Document maintenance, storage and coordination, as requested
• Communicate operational concerns and opportunities for improvement to department leaders
• Discuss incidents in weekly Operations meetings
• Know, understand and comply with CCSM’s standard operating procedures and policies
• Lead by example in setting a positive, supportive and team driven culture in working with team members to effectively resolve issues in a timely manner
• Perform other related job duties or responsibilities as assigned

REQUIREMENTS

• 1-4 years of work experience in document preparation
• Bachelor's Degree with 1 year of work experience or equivalent experience in documentation preparation
• Working knowledge of GMPs, CFR and ICH guidelines preferred
• Excellent written communication skills and active listening ability
• Excellent time management skills for working within a fast paced, ever-changing environment
• Must be a self-motivated learner to critically evaluate situations, adapt quickly in making timely and independent decisions
• Excellent communication and leadership skills
• Strong analytical and problem-solving skills
• Ability to work with cross functional teams and build consensus
• Maintain a high regard for confidentiality while dealing with all clients, proprietary and pharmaceutical related information
• All Microsoft Office Products: Word, Excel, Outlook, PowerPoint
• Other company proprietary software
• Fluent in English and in French

If you are interested, you can send your cv : [email protected]

• Location: Mont-Saint-Guibert
• Type: Perm
• Job #15067

Our Partner located in Mont-Saint-Guibert is looking for a Project Manager Operations

ROLE

• Acts as a liaison between clients and CCSM.

• Actively participate in client meetings, as deem appropriate based on study and client needs. In some cases, this role may be required to organize and lead the meeting.

• Assist with creation, as applicable, and maintains a project timeline based on client needs

• Assist with the setup and implementation of clinical studies including, but not limited to, distribution of clinical trial material and ancillary supplies to ensure accurate and timely receipt to client of study materials. In some cases this role may be required to manage the setup and implementation.

• Reviews all client specific project details including the packaging, labeling, and distribution of clinical trial material and ancillary supplies with maximum attention to accuracy

• Work alongside Project Manager Solutions to ensure continue movement of assigned tasks.

• Work alongside assigned Project Manager in other regions as project needs are identified.

• Reviews and approves packaging, distribution, and return documents, as applicable • Reviews and monitors inventory thresholds and expiry dating, update client as needed data

• Assists in sourcing material as outlined in client specific documentation throughout the history of the project

• Provides distribution solutions for cold chain supplies and controlled temperature shipment needs

• Utilizes project management tools to ensure time management in adequate planning, evaluation, and submission of risk assessment timelines on projects • Issues accountability and reconciliation reports

• Partners with other team members in Operations to ensure processes and procedures are maintained.

• Works with team members to address, research and resolve issues and concerns raised by clients

• Maintains all client specific records, documents, reports, and correspondence

• Ensures project activities are documented and billed correctly

• Delegates, provides instruction, and assists in training, as identified by Director of Project Management of other Project Management Team members.

• Partners with Quality Assurance to develop or revise applicable documents (i.e. SOPs, Work Instructions, etc)

• Partners with Quality Assurance and team members to ensure compliance of SOPs and correct deviations in a timely manner

• Communicates operational and personal concerns and opportunities for improvement to department leaders

• Takes responsibility for personal skill development in continuing to learn current pharmaceutical standards and industry trends

• Knows, understands, and complies with the company’s standard operating procedures and policies

• Performs other related job duties or responsibilities as assigned

REQUIREMENTS

• 0-3 years of related work experience working with the principles and practices involved in cGMP and Clinical Trial Management

• Must possess a detailed and proactive approach to management in problem solving of daily operations

• Excellent interpersonal communication and listening skills

• Superior time management skills for working within a fast-paced environment

• Able to critically evaluate situations, and adapt quickly in making timely and independent decisions

• Must demonstrate a high level of initiative and the ability to work well independently and as a team member

• Confidentiality of all clients proprietary and pharmaceutical related information is essential

• Strong awareness of ownership of assigned projects and responsibilities

• Cultural awareness while working across regions with internal or external team members

• Microsoft Office Products: Word, Excel, Outlook, PowerPoint,

• Office Equipment: Telephone, calculator, photocopier, fax, and scanning machines

• Other Facility Equipment

• Other company proprietary software

• Fluent in French and in English

If you are interested in this position, you can send your resume to Dimitri Soupart : [email protected]

• Location: Mont-Saint-Guibert
• Type: Perm
• Job #14485

Project Manager Solution Walloon Brabant – CDI   Our client is actively looking for a Project Manager Solution to strengthen its activities. Our partner is active in the pharmaceutical sector and is looking for a person with a solid experience as Project Manager in the pharmaceutical sector and who has worked in clinical trial environment.   What are your responsibilities? Coordinates with the Business Development Team regarding client contract creation specifications Creates and maintains a project timeline based on client needs Acts as a liaison between clients and the company. Organize and lead client meetings, as deem appropriate based on study and client needs. Manages the setup and implementation of clinical studies including, but not limited to, packaging and labeling, dispensing, distribution of clinical trial material and ancillary supplies to ensure accurate and timely receipt to client of study materials Provides packaging solutions to clients based on their need and estimated start date Work alongside Project Manager, Operations to ensure continue movement of assigned tasks. Work alongside assigned Project Manager in other regions as project needs are identified. Initial procurement packaging components and ancillary supplies required to complete project as applicable to specific project needs. Provides label text requirements for clinical trials, with assistance from a third party who can provide translation and regulatory requirements Utilizes project management tools to ensure time management in adequate planning, evaluation, and submission of risk assessment timelines on projects Ensures that accurate billing of project hours are documented and billed correctly. Partners with other team members in Operations to ensure processes and procedures are maintained. Works with applicable department manager(s) to address, research, and resolve issues and concerns raised by clients Delegates, provides instruction, and assists in training, as identified by Director of Project Management of other Project Management Team members. Partners with Quality Assurance to develop or revise applicable documents (i.e. SOPs, Work Instructions, etc) Partners with Quality Assurance and team members to ensure compliance of SOPs and correct deviations in a timely manner Communicates operational, personal concerns, and opportunities for improvement to department leaders   Who are you? Ability to lead, coach, and mentor employees to provide work direction in resolving issues as they arise  Must possess a detailed and proactive approach to management in problem solving  Exceptional interpersonal communication and listening skills  Superior time management skills for working within a fast-paced environment  Able to critically evaluate situations and adapt quickly in making timely and independent decisions  Must demonstrate a high level of initiative and the ability to work well independently and as a team member  Confidentiality of all clients’ proprietary and pharmaceutical related information is essential  Strong awareness of ownership of assigned projects and responsibilities  Cultural awareness while working across regions with internal or external team members  Fluent in French and English What can you expect? A permanent contract is offered for this function with a salary package matching your skills & experience. The opportunity to develop your skills or to evolve within this company is also open. You’re interested in this job? We kindly invite you to send an e-mail to [email protected]

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• Location: Mont-Saint-Guibert
• Type: Perm
• Job #13915

QA Validation Specialist

Brabant Wallon – CDI

#validation #QA #masterplanning #qualification #GMP #GDP #GCP

Are you interested in the pharmaceutical industry and putting your knowledge of validation to good use?

Our client is actively looking for a QA Validation Specialist to strengthen its activities. Our partner is active in the pharmaceutical sector.

What are your responsibilities?

As QA Validation Specialist, you are in charge to

• Put in place an active SVMP and keep it live and up to date
• Ensure we have a validation system, sops and templates to enable us to perform
• Meet the ever increasing validation requirements of audits and inspectors
• Use risk-based approaches to make validation activities efficient, cost-effective and defendable
• Validation Master Planning
• Retrospective review of validation activities in order to prioritise and define future work
• Writing a site validation master plan
• Be able to lead a validation/qualification
• Take the lead for validation activities from a Quality Perspective
• Data Integrity risk assessment and principles

Who are you?

You are graduated as a Pharmacist’s degree or a Master Science. You have 5 years of experience in QA. You have experience in wide range of validation activities-facility qualification, equipment qualification, process validation, cleaning validation/verification. Knowledge of GMP, GDP and GCP is required. You fluently speak French and English.

What can you expect?

A permanent contract is offered for this function with a salary package matching your skills & experience. The opportunity to develop your skills or to evolve within this company is also open.

 

• Location: Mont-Saint-Guibert
• Type: Perm
• Job #15494

Director of Project Management

Mont-Saint-Guibert – CDI

#Management #project #job #director

You have a strong experience in project management? You are an efficient person? You can handle different projects simultaneously owing to your organizational skills? Keep reading your future job description.

Our partner is looking for a Director of project management to join its team. This is a global pharmaceutical and services company with a unique combination of businesses focused on providing access to medicines to improve the quality of people's lives around the world

 

What are your responsibilities?

To be successful as director of project management, here are your tasks:

• Provides leadership through the guidance, direction, feedback, and training of direct reports in activities and policies to achieve high performance levels
• Allocation of projects, studies and customers to Project Managers assuring an equable repartition.
• Review the department revenues and revenue forecast.
• Review and approve quotes and budgets within the Project Management Department.
• Conducts and leads team meetings to ensure training for direct reports is in accordance with SOPs and company policies
• Leads by example in setting a positive and supportive team driven culture to effectively resolve personnel performance and other issues in a timely manner
• Responsible for all aspects of the project management for Phase I, II, III, IV clinical studies
• Coordinates where appropriate with the Business Development Team regarding strategic issues / client relationship, as well as regarding client contract creation specifications
• Proposes our distribution solutions for cold chain supplies and controlled temperature to the customer
• Utilizes project management tools to ensure time management in adequate planning, evaluation, and submission of risk assessment timelines on projects actively promoting best practice in these and other activities for team
• Ensures accurate billing of project planning hours and activities are documented and billed correctly
• Acts as a liaison between clients and company. Manages periodic business review meetings with clients as required ; coordinating with other internal colleagues as well as clients. Domestic and occasional international travel to clients may be deemed necessary and will be evaluated on a case by case basis.
• Works with Management, Operations and across our facilities and activities as required to maintain to address, research, and resolve issues and concerns raised by clients
• Works closely with Director colleagues to drive PM agreed initiatives and objectives.
• Collaborates with Director colleagues to address any issues, with clients or internally, that may arise, and contribute to continuous improvement, working toward harmonizing client experience, processes, and systems
• Communicates operational and personal concerns and opportunities for improvement to department leaders along with recommendations for resolution
• Takes responsibility for personal and team skill development in continuing to learn current pharmaceutical standards and industry trends
• Knows, understands, and complies with the company’s standard operating procedures and policies
• Performs other related job duties or responsibilities as assigned
• Regular 1:1 meetings with the individuals in the Project Management team, reviewing project status, set and review goals, identify training needs and discuss development.
• Training and coaching the department’s Team Leaders.
• Attend directory meetings and be a part of the strategic management group.
• Participating in Kick-off meetings and contribute to RFIs accordingly
• Supporting Business development activities and/or support project related initiatives.

 

Who are you?

Qualifications and Experience :

Experience:

• 8+ years or related work experience and/or equivalent work experience relative to the knowledge of principles and practices involved in cGMP and Clinical Trial Management
• Experience in staff management desirable

Skills:

• Ability to lead, mentor, and coach team members
• Identify and ensure appropriate fit of skills / experience to project or task requirements within team
• Capable of handling projects in different stages of development alongside management responsibilities 
• Must possess a detailed proactive approach to management in problem solving of daily operations
• Exceptional oral and written communication skills, active listening ability, and excellent time management skills for working within a fast paced and ever-changing environment
• Must be a pro-active thinker and self-motivated learner to critically evaluate situations and adapt quickly in making timely and independent decisions
• Ability to own and handle challenging situations – using timely escalation where appropriate
• Confidentiality of all clients’ proprietary and pharmaceutical related information is essential
• Cultural awareness while working across regions with internal and external team members

 

Computer Skills:

• Excellent Microsoft Office Products: Word, Excel, Outlook, PowerPoint
• Experience in using a project management tool such as MS Project or Workfront

Language Skills:

• Fluent in French and English. Any additional language is an asset.