Quality Assurance Specialist – CSV & Conformity – Pharmaceutical

Groupe PARIMA is a Contract Development and Manufacturing Organization (CDMO), established in 1994. For over 25 years, we have developed an expertise in the development and manufacturing of non-sterile liquids, suspensions and semi-solid drug products. https://www.groupeparima.com/fr/

Quality Assurance Specialist – CSV & Conformity

The Quality Assurance Specialist – CSV & Conformity

From a quality assurance standpoint:

  • Manage the data integrity program.
  • Oversee the validation full lifecycle of software systems, ensuring they operate in compliance with cGMP, 21CFR11, GAMP5 requirements.
  • Manage the audit program (client and internal audits) – (active participation to regulatory inspections) and CAPA Program.

Responsibilities:

  • To put in place and maintain a procedure related to data integrity and ethical code of conduct for Groupe Parima employees.
  • To ensure that the data integrity principles, ALCOA, etc, are communicated and consistently followed by all employees working in the GxP areas.
  • To provide an annual training to Groupe Parima employees on data integrity
  • Oversee, from a quality assurance standpoint, the conformity of the quality system and the adherence to procedures and working instructions.

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  • To work with the senior CSV Manager to provide guidance on CSV documentation requirements and approaches.
  • To work with the CSV Manager to generate lifecycle CSV deliverables for each electronic system, including validation assessments and plans, risk assessments, software and configuration testing, reporting, and change management.
  • To put in place and maintain a procedure to establish the verification frequency of audit trails for GxP systems.
  • To review and approve the CSV documentation.

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  • To act as the principal host during the client audits and to actively participate to regulatory inspections (HC & FDA).
  • To manage the internal audit program including the internal audit of the IT Department.
  • To manage the CAPA programme: monitor and follow-up of deadlines and contact person to help departments implement CAPA.
  • To actively participate in employee training
  • Other relevant tasks

Skills and experience required:

  • BSc (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, GAMP 5 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. Excellent ability to interact with auditors, clients, employees and managers
  • Excellent technical writing
  • Bilingual (French and English).
  • Able to work in a demanding environment and meet deadlines
  • Team player

What we offer:

  • Medical – dental & travel benefits
  • Group retirement plan
  • Recognition program & social activities
  • Personal days
  • Employee assistance program & online medical service
  • Hot Beverages (Hot chocolate, Coffee, Mokaccino)
  • Accessible by public transit or free parking
  • Referral program
  • Subsidized meal program

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