Senior Microbiologist - Laboratory Quality Manager
- Provide quality management support and development for the implementation and maintenance of the quality management system within the laboratory,
- Maintain & support ISO9001, ISO13485, ISO17025 and cGMP certification and accreditation in the laboratory.
- To ensure all work in the laboratory is carried out in compliance with the Health and Safety policies.
- Take the lead in hosting customer/regulatory audits of the laboratory, ensuring actions/responses are delivered in a timely manner
- To identify and report any failures in the implementation of the quality system, to investigate such matters and recommend appropriate corrective action.
- Perform internal audits
- Perform regular CAPA's
- To initiate, investigate, control and analyse the recording and investigating of customer complaints.
- Oversee change control & GMP Risk assessments.
- Review process & equipment validation (URS, IQ, OQ, PQ)
- To be responsible for the Quality and GMP training of all site personnel.
- Regular liaison with customers, establishing tech methods and advising on requirements for testing.
To succeed in this challenging, people focused business, you will:
- Have strong knowledge of microbiology techniques and Quality Assurance Standards (ISO 17025 & GMP)
- 3 years + of laboratory experience
- Degree qualified in a relevant scientific field (preferably Biology)
- Ideally have internal auditing qualification (company will provide training)
- Excellent communication & the ability to deal with multiple stakeholders (internal & external)
- Self-starter attitude and the ability to influence/train people on Quality related activities in a laboratory environment.
This job was originally posted as www.totaljobs.com/job/75963855