Sr DSP Expert job in Reykjavík, Iceland

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Job type: Permanent

Discipline: Bioprocessing

Location: Iceland

This vacancy has now expired. Please see similar roles below...

Proclinical are recruiting for a Sr DSP Expert to join a pharmaceutical organisation. This role is on a permanent basis.

Responsibilities:

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.

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