QC Operations Manager
hace 18 días
Hatfield
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. \n \n Role: \n 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. \n \n Key duties will include: \n\n • 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.\n, • 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.\n, • Ensuring that all laboratory processes and equipment are covered by SOPs and ensure that all equipment is covered by maintenance and calibration procedures.\n, • 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.\n, • 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.\n, • To ensure efficient planning of all day to day activities conducted by the QC analysts and train staff for the QC functions.\n, • 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.\n, • To support internal and external audits processes and audit schedules as appropriate and support the preparation and hosting of competent authority inspections.\n, • To support the implementation of change control activities and contribute to QC laboratory continuous improvement programme.\n\n \n Your Background: \n\n • Educated to degree level or above in a science discipline with significant previous experience in a QC Management role.\n, • Experience of leading and approving QC testing in GMP Pharmaceutical environment.\n, • Established people management experience and proven experience of directly managing analytical teams.\n, • Extensive knowledge of Quality Control, Quality Assurance, Quality Systems, GMP, Regulatory Compliance and manufacture and packaging of pharmaceutical products.\n, • Good technical and scientific judgement and the ability to interpret complex data and present key findings.\n, • Demonstrated Knowledge, understanding and application of GMP Guidelines and Regulations.\n\n \n Apply: \n It is essential that applicants hold entitlement to work in the UK. Please quote job reference 197860 in all correspondence.