QC Laboratory Manager - Pharmaceutical Manufacturing
We are looking for a Quality Control Manager with 7-10 years experience and who is able to manage multiple laboratories with approximately 20-30 staff. The Laboratories will be made up ofr 4 Analytical & 4 Microbiology labs.
The role will include the following:-
- Ensure that Quality Control (QC) functions across the UK manufacturing sites operate in a safe manner and that all staff are suitably qualified and trained to undertake the tasks assigned to them.
- Manage the QC functions across the UK manufacturing sires to provide efficient and effective service to support the timely release of materials, components and products.
- Ensure that QC functions operate in a fully GMP compliant manner and in compliance with the filed regulatory dossiers for the products supported.
- Ensure that all QC animal testing facilities operate in compliance with their project licenses and in full compliance with the relevant legislation applicable to the testing of animals.
- Ensure that the test methods are robust and where animals have to be used are refined so that, as far as practicable their use is reduced to the minimum commensurate with the testing requirements of the products and the needs of the business
Duties, Responsibilities, Activities:
- Ensure all QC staff are suitably empowered and fully engaged with other business functions and that appropriate processes and systems are established and maintained to ensure the efficient, effective and compliant support of the site (and global) operations.
- Standard operating procedures including safe systems of work are developed and approved for all activities and operations undertaken by QC staff.
- Recruit, train, coach and mentor suitably qualified and knowledgeable people to ensure that they are able to carry out their duties and tasks in a compliant and safe manner in accordance with the relevant approved procedures.
- Coordinates an organises the efficient testing of materials, components and products (including investigatory, stability and other samples) as well as review and approval of results and data to support timely release of such materials to meet the needs of production, supply chain and other internal customers.
- Communicates effectively with team, senior management and internal customers and takeholders.
- Ensure regular safety monitoring of QC facilities is undertaken as needed.
- Where inspections and audits of QC facilities are undertaken ensure that any adverse observations and findings are fully evaluated and suitable CAPAs implemented and closed out in a timely manner to fully address the deficiencies raised.
- Ensue that accidents and incidents are fully investigated and documented, that near misses are recorded and that appropriate CAPAs are put in place so as to prevent occurrence/reoccurrence of such events.
- Ensure the QC team understand and comply with all relevant work related legislation and regulatory standards; including the relevant HSE, Medicine GMP, Home Office and Employment legislation relevant to the operations they undertake.
- Ensure that all QC staff and operations comply with site and corporate policies, guidelines and governance requirements and that appropriate records are maintained and reports provided when required.
- Ensure that all test methods and equipment are suitably qualified/validated.
- Provide technical/scientific advice and guidance as required.
- Drive implementation of Lean Sigma and Class A throughout the QC function using data to drive continuous improvement.
- Ensure all deviations and OOS events are thoroughly and effectively investigated to root cause and that appropriate CAPAs are identified and implemented.
In all activities be a role model for the successful implementation of the Global Quality Goals and values such that they truly become the mindset of the Global Quality Operations
Focus the team on Quality systems thinking and continuous improvement
Conduct regular performance reviews including appropriate role, project and GMP/HSE compliance aspects against agreed objectives and set targets
Leads and models the partnership with Global Supply Chain, Global Quality and other stakeholders towards open, inclusive and effective engagements in achievement of site and global objectives.
Engage with external authorities and stakeholders to influence opinion and promote the company and its operations and interests.
Minimum Experience Required:
- Degree in Chemistry, Biology or Biosciences field.
- 8 years post graduate QC or laboratory experience
- 5 years supervisory or management experience
- Experience as a project Licence Holder preferred
- Proven technical ability including knowledge of GMPQMS, test method validation, equipment qualification, lean and 6 Sigma, continuous improvement/business excellence.
- Excellent interpersonal skills including good communication, conflict management and leadership
- Organisation Information
- Number of subordinates: 26 with 6 direct reports. Range from Associate technicians to Team Leaders
- Financial Responsibility: Manage the QC expenditure and headcount to agreed targets.