QC Team Leader Documentation, GLIMS & Stability

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Job Title: QC Team Leader Documentation GLIMS & Stability

1. Purpose of the Position

The Documentation GLIMS and Stability Team Leader ensures the coordination of documentation activities the management of the GLIMS system and the oversight of stability studies. They organize the necessary resources to ensure that task deadlines are met. They coordinate activities related to updating specifications creating or revising procedures managing the stability program and overseeing documentation systems.

As GLIMS Team Leader they plan and execute GLIMS system updates train and support users ensure system maintenance and represent the Laval site as a subjectmatter expert within global teams. Through this cross-functional role they contribute to operational performance and compliance with regulatory requirements.

2. Main Responsibilities

ACTIVITY MANAGEMENT & PLANNING

• Organizes material and human resources to meet the needs of the documentation service GLIMS and the stability program.
• Ensures compliance with documentation standards (SOPs) for verification classification and archiving.
• Ensures appropriate follow-up with supervisors from various departments.
• Participates in meetings related to the stability program GLIMS and the quality system particularly regarding specification change control.
• Ensures the team maintains expertise and adheres to standards related to their functions.

GLIMS Function (in collaboration with the Documentation & GLIMS Specialist)

• Ensures periodic maintenance and updates of the GLIMS system.
• Prepares and delivers training for various users.
• Manages access requests (internal clients technicians supervisors developers).
• Performs the annual review of user lists roles and responsibilities.
• Provides technical support to GLIMS users.
• Participates in the implementation validation and continuous improvement of GLIMS systems.
• Contributes to updating paper specifications.

Stability Function (in collaboration with the Stability Specialist)

• Ensures compliance with deadlines for executing stability studies.
• Oversees chamber placements and removals of stability batches.
• Participates in the opening review approval and closure of stability studies.
• Performs statistical control of stability processes develops risk mitigation plans and informs the supervisor of deviations and required actions.
• Ensures planning for the release of stability files.

GMP and HSE

• Ensures compliance with GMP and applicable procedures.
• Prepares reviews and updates Standard Operating Procedures (SOPs) required for proper laboratory operations.
• Ensures follow-up of personnel qualifications.
• Participates in the analysis of events and incidents and in the development of corrective actions.
• Contributes to deviation writing in collaboration with Quality Assurance.
• Applies HSE directives procedures and instructions daily.
• Participates in the execution of PASS actions for their sector.

3. Management Responsibilities

• Promotes a work environment conducive to performance and collaboration.
• Ensures communication between management and the team.
• Participates in employee evaluation and development including identifying training needs.
• Evaluates and coordinates overtime.
• Manages vacation planning according to operational needs.
• Informs management of workforce requirements.
• Plans and coordinates documentation GLIMS and stability activities related to products and analytical projects.

4. Resources

No budget management responsibilities. Expenditures are under the responsibility of the department manager.

5. Required Knowledge and Skills

a) Education

College Diploma (DEC) in Analytical Chemistry or ChemistryBiology or a Bachelors degree in Chemistry or Biochemistry.

b) Languages

French and English.

c) Experience and Specific Knowledge

• Minimum 3 to 5 years of experience in Quality Control operations in the pharmaceutical industry or a related field.
• Experience in a pharmaceutical analytical laboratory.
• Knowledge of Canadian and international GMP/GLP standards.

d) Technical Skills

• Ability to work in both official languages.
• Knowledge of reference standards (USP BP).
• Knowledge of GMP regulations (Health Canada FDA European Standards).
• Document management expertise.
• Strong knowledge of analytical techniques and laboratory instruments.

e) Knowledge and Abilities

• Attention to detail and rigor in managing files and data.
• Strong organizational skills autonomy and ability to manage priorities.
• Team spirit.
• Ability to manage multiple files simultaneously.
• Flexibility.

6. Key Professional Relationships

Internal partners: Laboratory services Quality Assurance Compliance Laboratory teams.
External partners: QC contact during audits laboratories external clients etc.

We are an Equal Opportunity Employer. We are committed to building diverse teams representative of the patients and communities we serve and we strive to create an inclusive workplace that cultivates collaboration.