DSP Operations Senior Technician
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Proclinical are recruiting for a DSP Operations Senior Technician to join a pharmaceutical organisation. This role is on a permanent basis and is located in Reykjavik.
- Conduct cGMP actions within Grade CNC, D, and C areas.
- Offer SME for DSP processing steps as and when needed.
- Serve as an SME writer/evaluator and/or approver for authored processes, SOPs, BMRs and any other cGMP documentations within spa of knowledge.
- Assume ownership of deviations, such as guiding and arranging investigations, when necessary, to assist with recognising root cause and suitable corrective actions.
- Guarantee QMS records are instigated, progressed, and closed within the company's outlined KPIs.
- Monitor and guarantee manufacturing actions are carried out rendering to cGMP.
- Train new starters to partake in accomplishing a multi-skilled and engaged DSP team.
- Get involved in tasks that include any other divisions within the company.
- Constantly recognising process improvement to aid in producing and preserving a lean, flexible and agile manufacturing facility.
- Other duties may be assigned.
Key Skills and Requirements:
- Educated to a degree level in a pertinent field or equivalent work experience.
- Expertise on downstream purification procedures for production of monoclonal antibodies and recombinant protein therapeutic products.
- Acquaintance with operating downstream processing equipment.
- Familiarity with purification practices, scale up, technology transfer and process validation actions.
- Demonstrable experience within a biopharmaceuticals or technical field would be ideal.
- Exhibited experience in training others.
- Past involvement assisting with pre-approval inspections (PAI) and working with global regulatory agencies which involves the FDA and EMA.
- Knowledge of cGMP compliance and affiliated documentation.
If you are having difficulty in applying or if you have any questions, please Patrick Turbidy on +44 203 530 5120.
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.