WHO ARE THEY:
Very exciting opportunity to join a unique manufacturing company, who are currently seeking a Senior QC Scientist to join their team on a permanent basis.
- To prioritise, sample, test and release raw materials, intermediates, and finished products to strict timescales, to support the business requirements.
- To review the compliance of QC test methods and associated equipment required in support of product release.
- Deputising for the QC Manager when required.
Duties & Responsibilities
Analytical QC Testing:
- Sampling and analytical testing of raw materials, intermediates, and finished products in accordance with approved procedures and current pharmacopoeias.
- Ensuring that procedures are carried out carefully and accurately to eliminate errors.
- Complete laboratory investigations in support of ‘Out of Specification’ results in a timely manner.
- Stability testing of products for new formulations and ongoing stability trials, using physical (e.g., pH) and instrumental (e.g., HPLC, UV) techniques, as appropriate.
- Complete quality actions (i.e., CAPA, Change Control, Audit) to agreed completion dates.
- To contribute to the preparation of Quality reports, including analytical reports (for raw materials and finished products) and Certificates of Analysis (CoA) (for finished products).
- Writing/reviewing Standard Operating Procedures (SOPs).
- Review of GMP documentation and data (Test QR’s, SOP’s, protocols, reports etc).
- To support activities to source and qualify equipment required in support of QC testing to comply with current European Pharmacopoeia and ICH requirements.
- Calibrating analytical equipment, as and when required.
- Working with all members of staff to maintain and develop the positive progressive culture within the company.
- Observing and complying with Good Manufacturing Practice (GMP).
- Observing and complying with company Health and Safety Policies.
- Observing and complying with company Standard Operating Procedures (SOPs).
- Undertaking any other duties, either for this department or any other department within the business, which may be requested by the Line Manager, for which training and/or an explanation has been provided and understood.
Qualifications & Experience:
- Educated to degree level in an appropriate scientific discipline with experience in a biopharmaceutical or closely related industry.
- Experience in an analytical laboratory environment together with knowledge of regulatory requirements.
- Computer literate.
- Previous experience working in GMP laboratory.
- Previous experience managing product stability/trend/control chart datasets.
- Previous experience executing ELISA assays.
Applications are encouraged from all sections of the community.