Quality Assurance Specialist - CSV & Conformity - Pharmaceutical

Groupe PARIMA; Montreal; On-site; CAD 80,000 - 100,000; Full time

Job summary

A leading pharmaceutical company is seeking a Quality Assurance Specialist – CSV & Conformity in Montreal. You will oversee data integrity, compliance with GMP regulations, and manage the internal audit program. An ideal candidate will possess a BSc in a relevant field and have extensive experience in quality assurance within the pharmaceutical industry.

Benefits

Recognition program & social activities

Personal days

Employee assistance program & online medical service

Accessible by public transit or free parking

Qualifications

• Minimum of 5 years experience in Quality Assurance within the pharmaceutical industry.
• Expertise in 21CFR11, GAMP5, and GMP requirements.
• Bilingual in French and English.

Responsibilities

• Manage the data integrity program and audit program.
• Ensure adherence to quality system procedures.
• Conduct training on data integrity principles.

Skills

Attention to detail

Communication

Technical writing

Team player

Education

BSc in Chemistry, Biochemistry, Microbiology or related discipline

Tools

Quality Management Systems (QMS)

Data Integrity Principles

Job description

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 :

• Recognition program & social activities
• Personal days
• Employee assistance program & online medical service
• Accessible by public transit or free parking