Currently working exclusively with a high-profile biotech in the UK who are in need of a Senior QA Specialist to join the Projects team within QA. The purpose of this role is to provide start up QA support to the qualification and licensing of new sterile fill and finish suites and there provide ongoing QA operational support.
- Improve efficiency of release process whilst maintaining compliancy
- Deliver documentation work around investigation of media fill failures (writing SOPs)
- Act as SME on fill/finish processes from Quality perspective.
Other responsibilities in this role would be:
- Oversee quality of GMP operations to ensure adequate and timely release of GMP compliant product.
- Provide direct quality team support during customer and regulatory audits.
- Ensures that all manufacturing documentation e.g. BMR’s, reports are reviewed and approved on batch completion, and forwarded to QP for on-time batch release.
- Review quality systems documentation including Deviations, Change Controls and CAPA’s.
- Investigate problems in conjunction with Manufacturing / Analytics and other subject matter experts to determine corrective and preventive actions.
- Review Risk Mitigation documentation, validation documents, FMS and Engineering documents, Lab OOS, SOP’s, and Policies.
- Supporting quality related customer complaint investigations and trending activities.
- Monitoring the progress of GMP regulated manufacturing and/or GMP analytics processes through all departments to ensure compliance with specifications and GMP.
- Provides line clearance checks including pre-batch manufacture or testing walk rounds at appropriate and quality critical stages of the batch manufacturing / testing process.
- Ensuring the effective communication of key information affecting product release to all relevant parties.
To be successful in this role, you will have the following skills and experience:
- A level / National Certificate in Life Sciences or equivalent
- Higher National Certificate or Degree in Life Sciences is desirable.
- Significant experience working within Pharmaceutical QA including experience of supporting validation and sterile operations.
- Solid working knowledge of GMP & Quality related pharmaceutical regulations & standards including sterile drug product manufacturing.
- Experience of having worked in an ATMP / Biologics Manufacturing environment preferable.
Start Date: ASAP
Duration: TBC (probably 6 months)
On vs Off Site: Ideally on-site at least 3 days per week (rest can be from home)
Interested? Get in touch by sending your CV to firstname.lastname@example.org or give me a call on +31202044502. You can also refer a friend and earn 250 euros!