QA Officer

QA Officer focuses on batch record review and product: review, approval and release of batch production records and quality control testing data.

What the role involves

• Batch Record review and product: Review, approval and release of Batch Production Records and Quality Control testing data.
• Non-conformance: Coordinate and approve/manage to completion any non-conformances, deviations and out of specifications.
• Documentation Management: Writing, reviewing and approving internal procedures. Release and issuance of procedures and archiving previous revisions.
• Change Control: Review and approval of change controls to ensure all changes to procedures and processes are assessed and implemented correctly.

Skills and requirements

• BSc/BA degree in biology, chemistry, biochemistry, bioengineering, or a related life science field.
• Experience of working within a Quality Assurance or Quality Systems function for a Pharmaceutical, Medical Device, Life Science or Biotechnology company.
• Experience of working within a cGMP environment.
• Experience of working to ISO 9001, ISO 13485, 21CFR part 820 or EudraLex Volume 4, Part II.

Confirmed role details

• Organise and participate in internal quality related training sessions.
• Internal Audits: Participation in the completion of the internal audit schedule. Conducting the internal audits, reporting any findings and tracking completion of corrective action.
• Supplier Quality: Assist in the QA approval of incoming materials and approval of QC testing for incoming materials.
• Environmental Monitoring of the ISO 7 Cleanroom during weighing operations.

Candidate fit

• Ability to critically review documentation.