DSP Operations Senior Technician 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 DSP Operations Senior Technician to join a pharmaceutical organisation. This role is on a permanent basis and is located in Reykjavik.

Responsibilities:

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.

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Salary

Highly Competitive Salary

Location:

Wrexham, Wales

Proclinical is seeking a Senior Principal Scientist to lead strategic projects in biomanufacturing processes, focusing on API/Drug substance processing.