Quality Assurance Specialist

1 week ago

Montreal, Quebec, Canada Groupe PARIMA Full time
Job Summary

We are seeking a highly skilled Quality Assurance Specialist to join our team at Groupe PARIMA. As a Quality Assurance Specialist - CSV & Conformity, you will be responsible for ensuring the quality and integrity of our CSV and conformity processes.

Key Responsibilities
  • Manage the data integrity program, ensuring that all data is accurate, complete, and compliant with regulatory requirements.
  • Oversee the validation of software systems, ensuring they operate in compliance with cGMP, 21CFR11, and GAMP5 requirements.
  • Manage the audit program, including client and internal audits, and actively participate in regulatory inspections.
  • Develop and maintain procedures related to data integrity and ethical code of conduct for Groupe PARIMA employees.
  • Communicate and ensure consistent adherence to data integrity principles, ALCOA, etc., among all employees working in GxP areas.
  • Provide annual training to Groupe PARIMA employees on data integrity.
  • Oversee the conformity of the quality system and adherence to procedures and working instructions.
  • Work with the senior CSV Manager to provide guidance on CSV documentation requirements and approaches.
  • Generate lifecycle CSV deliverables for each electronic system, including validation assessments and plans, risk assessments, software and configuration testing, reporting, and change management.
  • Establish and maintain a procedure to verify the frequency of audit trails for GxP systems.
  • Review and approve CSV documentation.
  • Act as the principal host during client audits and actively participate in regulatory inspections.
  • Manage the internal audit program, including the internal audit of the IT Department.
  • Manage the CAPA program, monitoring and following up on deadlines and contacting departments to implement CAPA.
  • Participate in employee training and development.
Requirements
  • Bachelor's degree in Chemistry, Biochemistry, Microbiology, or a related discipline from a Canadian university or diploma recognized by a Canadian university or accreditation body as equivalent in a scientific field.
  • Minimum of five (5) years of experience in Quality Assurance in the pharmaceutical industry, with experience in IT system validation, audits, and quality systems.
  • Minimum of 5 years of applied CSV experience in the pharmaceutical or medical device industry.
  • Expertise in the application of Health Canada and FDA GMP requirements, including 21CFR11, GAMP5 guidance pertaining to highly complex automated electronic systems for Quality and manufacturing/packaging and engineering operations.
  • Expertise in electronic quality management systems (QMS), QMS product management, and systems validation.
  • Excellent knowledge in system integration methodologies and tools.
  • Thorough knowledge and understanding of Canadian (Health Canada), American (FDA), and European Good Manufacturing Practices (GMP).
  • Knowledge and thorough understanding of data integrity principles and computer system validation (21CFR11, GAMP5).
  • Technical and regulatory expertise in information technology systems supporting GxP activities.
  • Good knowledge of ICH Q9 and Q10 (Risk Management and Quality System).
  • Excellent communication skills and ability to interact with auditors, clients, employees, and managers.
  • Excellent technical writing skills.
  • Bilingual (French and English).
  • Able to work in a demanding environment and meet deadlines.
  • Team player.

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