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:

• 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.
• Authoring, checking or approval of documentation: SOP’s, LBPs, spreadsheets, methods, reportsand protocols to ensure they are in conformance with Marketing or Clinical Trial Authorisations and / or regulatory expectations.
• Ensuring that all laboratory processes and equipment are covered by SOPs and

  ensure that all equipment is covered by maintenance and calibration procedures.

• 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.

• 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.
• To ensure efficient planning of all day to day activities conducted by the QC analysts and train staff for the QC functions.
• 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.
• To support internal and external audits processes and audit schedules as appropriate and

  support the preparation and hosting of competent authority inspections.

• To support the implementation of change control activities and contribute to QC laboratory continuous improvement programme.

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

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