QC Operations Manager

Talentmark; Hatfield; On-site; GBP 60,000 - 90,000; Full time

Job summary

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

This role oversees QC product testing (bulk and finished product), incoming goods testing and ensures testing is completed to agreed specifications and lead times. You will lead the QC team, author and approve SOPs, manage investigations (OOS/OOT) and CAPAs, and support audits and regulatory inspections.

Qualifications

• 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.

Responsibilities

• Approve QC testing conducted on bulk product, stability and finished product and approve or reject starting materials or packaging component in accordance with GMP.
• Authoring, checking or approval of documentation: SOPs, LBPs, spreadsheets, methods, reports and protocols to ensure compliance with regulatory expectations.
• Ensure that all laboratory processes and equipment are covered by SOPs and that all equipment is maintained and calibrated.
• Lead laboratory investigations, including OOS or OOT results, ensuring investigations and CAPAs meet timelines.
• Manage all direct reports including contractors, ensure 1:1 meetings, up-to-date job descriptions and performance reviews.
• Plan day-to-day QC analyst activities and train staff for QC functions.
• Coordinate testing for EU importation and maintain good relations with contract laboratories.
• Support internal and external audits and competent authority inspections; assist with change control and continuous improvement.

Skills

QC Testing Leadership

People Management

Data interpretation

GMP Knowledge

Education

Bachelor's degree in science

Job description

Talentmark are recruiting for a QC OperationsManager, 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 andensure that all equipment is covered by maintenance and calibration procedures.
• Leadinglaboratory 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 andsupport 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 197860 in all correspondence.