CPL are actively recruiting for a QC Systems Specialist to support a Manufacturing department by maintaining and improving the QMS.
- Write, review and approve site documentation in accordance with regulatory and site requirements.
- Conduct Site Internal Audits ensuring alignment with regulations, global documents and site documents
- Responsible for challenging current procedures interpretation of trend data and for making necessary revisions to Quality programs to afford optimisation and further development of existing Quality standards and overall compliance.
- Oversight and management of Quality Risk Management process and for the embedding of QRM principles within the Quality Framework
- Responsible for trending programs associated with deviations/CAPA’s/Change Controls. Ensuring ouputs are providing key indicators as to program efficacy.
BSc, MSc or PhD in Science or Engineering related subject
- Relevant 3- 5 years working within a Quality or Manufacturing department in a Pharma or Biotech industry.
- Previous QMS or QRM experience
- Previous Computer Systems Validation or Data integrity experience