QA Manager - Pharmaceutique

Quality Manager

The Quality Manager is responsible for providing immediate quality leadership and operational support within a GMP-regulated sterile manufacturing environment. The role focuses primarily on Quality Assurance oversight of qualification and validation, material and supplier qualification, and maintenance and calibration systems.

Key Responsibilities:

Qualification and Validation Oversight:

• Provide QA oversight and hands-on support for qualification and validation activities, including:

o Equipment qualification

o Utilities qualification (e.g. HVAC, gases)

o Computerized systems validation

• Review and approve qualification and validation protocols, reports, and deviations
• Ensure validation lifecycle principles are applied and maintained
• Support aseptic process validation activities from a QA perspective
• Material and Supplier Qualification
• Establish, review, and maintain material qualification processes, including starting materials, primary packaging components, and consumables
• Ensure suppliers are appropriately qualified and approved through risk-based assessments and audits (as applicable)
• Review and approve supplier-related changes, deviations, and quality notifications
• Support the maintenance of quality agreements with suppliers

Maintenance and Calibration Oversight:

• Provide QA oversight of maintenance and calibration systems for GMP-critical equipment and utilities.
• Review and approve maintenance and calibration plans, records, deviations, and change controls.
• Ensure calibration status is maintained and appropriately documented to support GMP compliance and data integrity.

Operational QA Support:

• Provide hands-on QA support to daily operations, including:

o Deviation and investigation management

o Change control assessment and approval

o CAPA definition and effectiveness follow-up

o Risk assessments related to equipment, utilities, and materials

• Support SOP updates and remediation activities related to qualification, validation, and technical systems.

Requirements for the Role:

• University degree in a scientific or engineering discipline (e.g. Pharmacy, Chemistry, Engineering, Life Sciences).
• Minimum of 5–8 years of experience in Quality Assurance within a GMP-regulated pharmaceutical environment.
• Demonstrated experience supporting sterile manufacturing
• Proven hands-on experience with equipment qualification, validation, and technical quality systems.
• Strong knowledge of EU GMP requirements, including Annex 1 and Annex 15.
• Practical understanding of qualification and validation lifecycle principles.
• Experience with supplier qualification and quality oversight
• Solid understanding of maintenance and calibration requirements in GMP environments.
• Clear, concise documentation and communication skills.
• Pragmatic, solution-oriented approach with sound quality judgment.
• Ability to work independently and integrate quickly into an existing organization.
• Demonstrates strong GMP awareness and attention to detail