QC Operations Manager

Talentmark are recruiting for a QC Operations Manager, to join a well-established and successful global pharmaceutical company, based in Hatfield, Hertfordshire, on a permanent basis.

Role:

This role is responsible for the oversight of QC product testing (bulk and finished product), incoming goods testing and ensuring that all materials/bulk and finished product that require testing by the laboratory are done so according to agreed specifications and procedures and within agreed lead times.

Key duties will include:

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• To approve QC testing conducted on bulk product, stability and finished product and approve or reject starting materials or packaging component in accordance with Good Manufacturing Practices.
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• Authoring, checking or approval of documentation: SOP’s, LBPs, spreadsheets, methods, reports and protocols to ensure they are in conformance with Marketing or Clinical Trial Authorisations and / or regulatory expectations.
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• Ensuring that all laboratory processes and equipment are covered by SOPs and ensure that all equipment is covered by maintenance and calibration procedures.
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• Leading laboratory investigations, including those related to OOS or OOT analytical results, ensuring they are investigated according to the agreed SOP and that any CAPAs are completed to agreed timelines.
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• To manage all direct reports including any contractors to ensure that regular 1:1 meeting take place and that Job Descriptions, Objectives and performance reviews are up to date and completed on time.
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• To ensure efficient planning of all day to day activities conducted by the QC analysts and train staff for the QC functions.
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• To coordinate and support testing for EU importation, ensuring that a good working relationship is maintained with the contract laboratories and any issues/deviations are resolved.
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• To support internal and external audits processes and audit schedules as appropriate and support the preparation and hosting of competent authority inspections.
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• To support the implementation of change control activities and contribute to QC laboratory continuous improvement programme.
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Your Background:

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• Educated to degree level or above in a science discipline with significant previous experience in a QC Management role.
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• Experience of leading and approving QC testing in GMP Pharmaceutical environment.
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• Established people management experience and proven experience of directly managing analytical teams.
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• Extensive knowledge of Quality Control, Quality Assurance, Quality Systems, GMP, Regulatory Compliance and manufacture and packaging of pharmaceutical products.
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• Good technical and scientific judgement and the ability to interpret complex data and present key findings.
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• Demonstrated Knowledge, understanding and application of GMP Guidelines and Regulations.
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Apply:

It is essential that applicants hold entitlement to work in the UK. Please quote job reference 197860 in all correspondence.