over 1 year ago
I am currently working with an exciting Rare Disease Bio-pharma based near Edinburgh who are looking for a QA specialist to join their team on a permanent basis. The ideal candidate would need a biologics experience to be considered.
The positions will provide QA support for the manufacture of products in order to ensure each product is manufactured and supplied to the marketplace in compliance with cGMP requirements.
The role involves but isn't limited to:
- Ensure that an appropriate level of product batch record reviews are carried out at the CMO facilities, as necessary, prior to the release of the product for sale and distribution
- To review departmental standard operating procedures SOPs
- Identifying and addressing any gaps relating to product quality and GMP compliance.
- Prepare and maintain Technical Quality Agreements with third-party contractors manufacturing organizations
- Regularly review non-conformances e.g. process deviations, out of specification/trend results.
- A Life Science degree or equivalent
- Sound knowledge of the principles of solid and semi-solid dosage manufacturing processes (tablets, capsules, gels, creams, ointments)
- Familiar with Quality Management Systems
- Sound knowledge of QC and Stability chemical analytical testing techniques for solids and semi-solids
- Familiar with the regulatory requirements for validation activities as applied to manufacturing and packaging processes, analytical methods, cleaning procedures, computerized systems
- Familiar with the appropriate EU Directives, EU and USA regulatory processes, ICH Guidelines