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The ideal candidate would be expected to have experience of Upstream manufacturing in a GMP environment. The successful candidate would be expected to be able to guide and mentor others. In addition, they would be expected to be able to participate in/complete all associated Quality functions, e.g. CAPA's, authoring documents/training packages, root cause analysis etc.
As a Manufacturing Operator you will be an expert in performing (and understanding the theory of) all manufacturing activities involved in the secondary manufacture of finished products. You will ensure all manufacturing activities are conducted in a safe and cGMP/regulatory compliant manner.
The successful Manufacturing Operators will have the following qualifications, skills and experiences:
-BSc in biotechnology, chemistry, bio/chemical engineering or comparable preferable.
-Good experience and knowledge of aseptic manufacturing of (in vial/pre-filled syringe) biopharmaceutical products in a cGMP regulated environment.
-Practical experience of URS, FAT, SAT, IQ, OQ, PQ would be beneficial.
-Experience of allocating activities to and coaching, training and mentoring of others.
-Experience of Pre-Approval Inspections (PAI) and international regulatory agencies including the FDA and EMA.
-Expertise working with up-to-date cGMP compliance and associated documentation.
-Fluent command of the English language, both spoken and written
Alternatively, please click on the link below. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference SH40342 in all correspondence.
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