Leading Pharmaceutical Manufacturer based in Cheshire seeks an experienced QC Manager on a 14-month FTC Maternity Cover basis.
About the role:
The role holder will be responsible for ensuring the framework for delivery of efficient, effective and integral test results compliant with regulatory and customer/client standards is implemented and maintained in a consistent and sustainable manner throughout the Quality Control department. The role holder will be accountable for the management of the Quality Control laboratory and associated functions in support of the sites commercial activities and agreed departmental targets.
Duties may include:
To ensure relevant regulatory standards (GMP, GLP, UK Statutory Law etc) are adhered to within the laboratory.
Mentor team members to aid delivery of critical tasks and ensure continual professional development.
Manage the day to day running of the laboratory ensuring the laboratory is at an appropriate state of readiness.
Ensure appropriate systems are in place to facilitate and document continuous improvement within the QC laboratory and associated functions.
Preparation, reporting and management of the QC departmental budget.
Organise recruitment, training and allocation of laboratory staff to deliver high quality analysis and reporting to meet site commercial timelines.
Ensuring that the testing of Raw/Starting Materials is conducted in an effective and efficient manner to support site manufacturing timelines and appropriate processes are in place for the investigation, reporting and escalation of out of specification results in a timely manner.
Ensuring that the testing of intermediate/finished products are conducted in an effective and efficient manner to support site dispatch timelines and appropriate processes are in place for the investigation, reporting and escalation of out of specification results in a timely manner.
Ensuring that the site stability testing programme is managed and maintained to meet all regulatory and customer/client requirements and that effective scheduling, reporting and escalation processes are in place to support this.
Ensuring the processes are in place for the effective coordination, execution and reporting of laboratory investigations. The role holder will be responsible for ensuring the clear and effective communication of the outcome of such investigations to internal stakeholders and, where necessary, external interested parties.
Manage laboratory technical / technology transfers.
Providing technical support and guidance to analytical teams as required.
Provide technical support and guidance to operational teams during investigations.
Any other activity deemed quality related by the Quality Assurance Head/Director
Provision of testing services to support site commercial activities, customer requirements and regulatory expectations.
Management and development of members of the QC Department to ensure appropriate levels of training, competence and capability throughout the department.
Promotion of continual improvement across the QC department.
Skills and experience:
Scientific degree and significant experience within a relevant role
Experience in the management and development of staff
Experience in the organisation, execution and reporting of multiple workstreams within a laboratory service provision environment.
Experience of stakeholder management within a contract manufacturing organisation, internally and externally.
Experience of engagement with regulatory authorities, third party auditors, scientific/technical bodies in the reporting, demonstration and explanation of QC testing activities.
Ability to read, write and follow written/verbal instructions
Product Quality Assurance
Continuous Improvement Process
Good Manufacturing Practices