Head of QC
A leading pharmaceutical client is searching for a Head of QC to join their team in the UK. The company specialises in various therapy areas including oncology, neurology, and gastroenterology, and employs several thousand across the globe.
The role of the Associate Director of Quality Control is to ensure that all materials that require testing by the laboratory are done so according to agreed specifications and procedures and within agreed lead times. The job holder must ensure that operations carried out within QC are carried out in accordance with the requirements of the company's Quality System, GMP Guidelines, and Industry Standards.
- To approve or reject starting materials or packaging components in accordance with Good Manufacturing Practices.
- To ensure that all Specifications, Test Methods, and procedures are approved and updated in conformance with the Marketing, Clinical Trial Authorisations and/or regulatory expectations.
- To ensure that all methods used that are not covered by regulatory filings are appropriately documented, approved, and validated.
- To ensure that all laboratory processes and equipment are covered by SOPs.
- To ensure that all equipment is covered by maintenance and calibration procedures.
- To ensure that all OOS or OOT analytical results are investigated according to an agreed SOP and that any CAPAs are completed to agreed timelines.
- To manage all staff ensuring that Job Descriptions, Objectives, and Appraisals are up to date and completed on time.
- To manage the analysis and reporting of any analytical data from third party contractors.
- To recruit and train staff for the QC functions, and design and implement systems and procedures to support their development.
- To design and implement systems and procedures for the efficient, productive, compliant, and safe operation of the production operation.
- To identify appropriate KPIs, implement systems and procedures for their routine measurement, and report as part of the Quality Management System.
- Establish continuous improvement capability for the productive, compliant, and safe operation of the production operations.
- To manage and control departmental expenditure within agreed budgets.
- To liaise with other functional/departmental managers so as to understand all necessary aspects and needs of operational development, and to ensure they are fully informed of operational objectives, purposes, and achievements.
- To contribute to the evaluation and development of operational strategy and performance in co-operation with the EML Management team.
- To ensure activities meet with and integrate with organisational requirements for quality.
- To support the implementation and management of stability programmes.
- To perform any other appropriate duties at the request of the Senior Director, EMEA Quality Operations.
- To provide oversight and support for the EU based import contract laboratory.
- To ensure all Data Integrity matters including equipment upgrades and activities are kept up to date with current Regulatory expectations.
- To manage all QC related projects and ensure that EML project governance requirements are followed.
- Interact proactively with other QC laboratories within EDCS site network.
Skills and Requirements:
- Ability to establish and maintain effective working relationships and communication links within EML, affiliated organisations, and other customers.
- Extensive knowledge of Quality Control, Quality Assurance, Quality Systems, GMP, Regulatory Compliance, and manufacture and packaging of pharmaceutical products.
- Good technical and scientific judgement.
- Ability to interpret complex data and present key findings.
- Demonstrated Knowledge, understanding, and application of GMP Guidelines and Regulations.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Katty Maia at +44 2038543317 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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