Job Purpose & Objectives

We are seeking a detail-oriented and proactive QA Specialist to join our QA Operations team. The QA Specialist acts as a crucial link between Quality Control operations and the quality system, ensuring our pharmaceutical products' quality, safety, and efficacy in compliance with cGXP conditions. As the on-the-shopfloor QA partner for the QC team, this role is essential in maintaining cGMP/cGLP compliance and upholding high-quality standards in our operations.

Key Responsibilities

Quality System:

• Provide on-the-floor QA support by advising on cGMP/cGLP and related quality assurance issues.
• Establish, implement, maintain, and continuously improve QA Operations documents and documentation.
• Initiate, participate in, document, review, and approve operational risk assessments.
• Lead efforts to resolve QC deviations and Out of Specification (OOS) situations; participate in investigations and review and approve related reports.
• Review and approve change requests, associated action plans, and documentation.
• Provide training for personnel regarding quality and cGMP requirements in classroom and shopfloor settings.
• Participate in self-audits, customer audits, and health authority inspections.

QC System:

• Review and approve operational documentation for completeness and compliance with cGMP/cGLP and regulatory requirements.
• Oversee the issuance and appropriate use of QC records, including methods and equipment qualification.
• Advise the Qualified Person on potential quality issues and disposition decisions.

Materials System:

• Review and approve incoming materials documentation.
• Release incoming materials upon review of documentation to ensure quality compliance.

Qualifications Skills and Experience

We are looking for a highly skilled QA Specialist with a strong background in biopharmaceutical manufacturing and quality assurance. The ideal candidate will have a deep understanding of GMP regulations and experience in a biotech environment, particularly with cell culture activities. They will possess strong problem-solving skills, a collaborative mindset, and the ability to develop practical solutions within the pharmaceutical regulatory framework.

• Education: MSc or equivalent in a scientific discipline, engineering, or a related field. Candidates should have the necessary skills, knowledge, and abilities typically acquired through hands-on experience in a biopharmaceutical manufacturing environment, especially in cell culture activities.
• Problem Solving: Ability to effectively use investigation techniques to identify issues and implement solutions within the regulatory framework.
• Teamwork: Strong interpersonal skills and the ability to work collaboratively in a team environment.
• Regulatory Understanding: Ability to define and implement pragmatic solutions that comply with pharmaceutical regulations.
• Language Proficiency: Fluent in French and English, with excellent communication skills in both languages.
• GMP Experience: At least 5 years of hands-on experience in GMP environments within pharmaceutical QA, QC, Manufacturing Science and Technology (MS&T), or sterile manufacturing settings.
• QC Methods: Experience with typical quality control methods used in the biotech environment, such as ELISA, SDS-PAGE, PCR, and in-vitro potency assays.
• Digital QA and Paperless QC: Familiarity with digital QA systems and a paperless QC approach, demonstrating adaptability to modern, technology-driven quality management processes.

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