Quality Assurance Specialist - CSV & Conformity - Pharmaceutical

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.
• 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.
• 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
Il y a plus de 30 jours