QC Operations Manager in Hatfield
Posted by Talentmark
Pay not stated
Hatfield · Permanent
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, reports and 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 71419 in all correspondence.
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