We are looking to appoint a QC First Line Manager on behalf of our client based at Porton Down Science Park in Salisbury.
The successful post holder will lead and manage a specialist GMP analytical chemistry/biochemistry laboratory to provide compliant testing of licensed pharmaceutical products.
Main Duties include:
Manage and lead the QC Analytical Services Laboratory to ensure the manufacturing deadlines are met.
Train QC staff within the QC Analytical Services Department in Procedures and Quality Management Systems to GMP requirements.
Manage and Track Compliance records for the QC Analytical Services Department, identify weaknesses, develop and implement improvements.
Project manage the implementation of new products, method development/transfer and equipment to completion and ensure clear communication is maintained between all parties.
Utilising technical skills to validate specialised chemical and biochemical tests procedures to internationally recognised regulatory guidelines.
Ensure that clinical pharmaceutical products are tested from raw materials and in-process samples to finished products to demonstrate that they meet the specification prior to each batch release for administration to patients.
Sign off authority for Pharmaceutical batch release tests.
Review and approval of SOPs, Protocols, Reports and Risk Assessments.
Host audits both from internal and external parties.
Write and review OOS investigations, deviation reports, CAPA’s, Quality Risk Assessments and Change Controls.
Have current right to work in the UK.
Previous experience of managing and leading a team and extensive knowledge of analytical/biochemical techniques within a cGMP laboratory environment.
Extensive knowledge of developing analytical methods, method transfer, equipment introduction and validation lifecycle.
Solid understanding of out of specification process and carrying out laboratory investigations.
Sound knowledge of compliance records and quality management systems within the pharmaceutical industry.
Clear communicator with excellent report writing and presentation skills.
Able to work to tight deadlines and the changing priorities to suit the needs of the business.
This role is inclusive of additional bonus as it will require you to work a shift rotation to support the manufacturing department.
If this role is of interest to you, please contact Carrie for more information or click apply!