Job Description
Blackfield Associates is currently assisting a leading clinical-stage biopharmaceutical company in their search for a Senior Quality Assurance Specialist based in central Stevenage.
If your skills, experience, and qualifications match those in this job overview, do not delay your application.
As the Senior Quality Assurance Specialist, you will be responsible for executing QA tasks to ensure compliance with local GMP facility processes during manufacturing and testing activities. Your duties will include:
- Overseeing QA aspects of the qualification and validation of manufacturing facilities, production, and QC testing equipment, in accordance with EudraLex Vol4, Annex 11 and 15, relevant FDA regulations, and industry guidelines.
- Collaborating with the Validation team to review and provide QA input to the Validation Master Plan, Validation Traceability Matrix, and Planned Preventative Maintenance control strategies for facilities, services, IT systems, and equipment.
- Participating in management reviews of process performance, product quality, and the pharmaceutical quality system, and advocating for continual improvement.
- Providing QA input and reviewing outsourced studies and services related to qualification, validation, and maintenance activities.
The ideal candidate for this position will have extensive experience in GMP manufacturing environments, particularly in sterile production, cleanrooms, and aseptic techniques. Basic experience in providing quality advice for qualification/validation activities would be desirable.
If you are interested in this opportunity, please send your up-to-date CV to Oliver@BlackfieldAssociates.com or call Oliver on 02392 314 792.