Job Description
We are seeking a skilled QA CQV Specialist to provide quality oversight of all validation and qualification activities.
* Ensure quality oversight of the qualification and validation activities of all facilities, utilities, equipment, computerised systems, cleaning processes, manufacturing processes, storage areas, controlled temperature units (CTUs), and shipping processes.
Required Skills and Qualifications
To be successful in this role, you will need:
* BSc or BEng in a Scientific or Engineering discipline (e.g. Biochemistry, Chemistry, Engineering).
* 4 to 5 years experience in Quality Engineering, Quality Assurance, or Quality Validation within a biologics, pharmaceutical, or medical device manufacturing environment regulated by FDA/EU guidelines.
* Strong understanding of validation requirements for a cGMP manufacturing facility.
* Excellent knowledge of GxP regulations applicable to biologics manufacturing (EU-GMP, FDA, ISO) and relevant industry standards (GAMP, ISPE, ISO, ASME, BPE).
Benefits
As a QA CQV Specialist, you will have the opportunity to:
* Support commissioning, qualification, and validation (CQV) activities associated with the site start-up project.
* Help ensure a smooth transition from project phase to routine operations.
* Maintain a strong understanding of cGMP regulations and guidance related to validation and qualification of facilities, utilities, equipment, computerised systems, cleaning, manufacturing processes, storage areas, CTUs, and shipping processes.
* Coordinate QA validation activities to ensure schedule adherence and on-time delivery of project milestones.
* Support performance management, recruitment, and training activities within the QA validation function as required.