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