Sr DSP Expert
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Proclinical are recruiting for a Sr DSP Expert to join a pharmaceutical organisation. This role is on a permanent basis.
- Guide and arrange investigations when necessary to aid in recognising root cause and suitable corrective actions.
- Monitor and guarantee manufacturing actions are carried out rendering to cGMP.
- Train new starts to partake in accomplishing a multi-skilled and engaged DSP team.
- Guarantee QMS records are instigated, progressed, and closed within the organisation's outlined KPIs.
- Offer SME knowledge for DSP processing steps when necessary.
- Assure the DSP suite and equipment is always preserved in a state of inspection promptness.
- Serve as an SME write/evaluator and/or approver for authored processes, SOPs, BMRs and any other cGMP documentations within knowledge span.
- Other duties may be assigned.
Key Skills and Requirements:
- Educated to a degree level in a pertinent field or adequate pertinent experience.
- Expertise on downstream purification procedures for production of monoclonal antibodies and recombinant protein therapeutic products.
- Familiarity with operating downstream processing equipment.
- Acquaintance with purification practices, scale up, technology transfer and process validation actions.
- Demonstrated experience in DSP in a biopharmaceutical or technical field would be ideal.
- Prior involvement in training others.
- Former experience assisting with pre-approval inspections as well as working with global regulatory agencies which involves the FDA and EMA.
- Knowledge in cGMP compliance and affiliated documentation.
If you are having difficulty in applying or if you have any questions, please contact Ruhee Saleh at +44 203 0590923.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.