Open role
QC Operations Manager
- Aggregated by CV-Library
- Hertfordshire
- Permanent
- Full Time
Job Description
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.
Your Background:
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.
Apply:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference (phone number removed) in all correspondence
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.
Your Background:
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.
Apply:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference (phone number removed) in all correspondence