Quality Control Senior Analyst

• To ensure that the conduct of analytical activities in the Quality Control Laboratory in the PMU meet the requirements of GMP, GCLP, The Health and Safety at Work Act 1974, COSHH Regulations and any other applicable legislation.
• To undertake Finished product, Raw Material, Containers and Stability testing in line with current specifications, protocols and Pharmacopeial standards.
• To be fully conversant with HPLC, FTIR, UV spectroscopy, TOC analysis and other physical/chemical testing methods to be able to interpret data and assess the validity of results
• To support the maintenance of the QC Pharmaceutical Quality System including documenting quality exceptions, investigating OOT/OOS and implementing Corrective & Preventative actions.
• To support new and existing staff by delivering competency based training on QC processes, equipment and systems.

Essential

• BSc in Chemistry, Pharmaceutical Science or related scientific discipline.

Desirable

• Membership of the Royal Society of Chemistry

Essential

• A minimum of 3 years' post-graduation experience in a GMP regulated QC laboratory
• Experience of a range of analytical chemistry techniques (including HPLC, UV, FTIR, dissolution, disintegration) and general wet chemistry testing
• Experience of Quality Management Systems including risk assessment, deviation reporting and change control
• Experience of equipment calibration and, management of maintenance schedules

Desirable

• Previous experience of working in the pharmaceutical industry.
• Experience of testing raw materials to pharmacopeial requirements
• Experience of conducting Root Cause Analysis, OOS/OOT and CAPA management
• Previous experience of equipment commissioning and qualification
• Experience of participating in quality audits, including regulatory inspections

Essential

• Demonstrated understanding of GCLP and GMP guidelines in a manufacturing environment
• Demonstrated ability to review GMP documentation completed or created by others including testing data, SOP, specifications and protocols.
• Ability to use GMP compliant computerised laboratory information systems
• Demonstrated ability to comply with standard operating procedures and to assess other staff's compliance with these procedures.

Desirable

• Demonstrated understanding of current regulations governing Specials manufacture and the role of the MHRA
• Demonstrated ability to interpret analytical data and make appropriate technical judgements
• Experience of using electronic documentation systems and electronic materials management systems
• Experience of undertaking COSHH assessments