Beschreibung
Qualification EngineerOur pharmaceutical client is currently undergoing a long term project to improve and develop their GMP and FDA compliance site-wide. One of the secondary sterile production teams has commenced validation and qualification documentation review, and need additional support on the project. They are searching for a hands-on qualification engineer to work alongside the team on a long-term co-operation.
Job and Project Description
- Support on an ongoing remediation programme to review qualification, validation and other production documentation.
- Gap analysis of existing documentation for compliance with GMP, FDA and client internal guidelines.
- Hands on writing and review of documentation.
- Support in developing ongoing strategies for qualification and validation of equipment and automation systems.
- Generation of qualification and validation plans and reports.
- Completion of existing qualification remediation activities.
- Work closely with the existing qualification/validation team.
- Comprehensive knowledge of technical and regulatory compliance requirements including GMP and FDA.
- Comprehensive understanding of aseptic manufacturing in the pharmaceutical industry.
- Strong experience of qualification of one or more of:
- Aseptic filling lines
- Visual inspection lines
- Clean rooms.
- Previous experience of aseptic process validation for compounding and aseptic filling processes advantageous.
- Knowledge of CSV also advantageous.
- Experience of documentation and archiving systems a plus.
- Soft skills: team player; hands on and task orientated approach; self-dependent; strong problem solving abilities.
- English language essential in written and spoken form.