I am currently working with a rapidly growing Pharmaceutical company based in Scotland who are looking to take on a QA Manager. The company is extremely well-funded and now would be a great time to join!
As QA manager, your principle purpose will be to provide QA support for the manufacture of products in order to ensure that each product is manufactured and supplied to the marketplace in compliance with cGMP requirements, Marketing Authorisations, company operating policies and procedures and business requirements
- Participate in the appropriate project management meetings in order to keep abreast of ongoing activities, identifying and addressing any gaps relating to product quality and GMP compliance.
- Prepare and maintain Technical (Quality) Agreements with third party contractor manufacturing organisations (CMOs) so that roles and responsibilities between the contracted parties are clearly defined and implemented
- Regularly review non-conformances e.g. process deviations, out of specification/trend results etc at the CMO to ensure that resulting investigations have identified the root cause(s), that suitable reports have been written and that corrective and preventative actions (CAPAs) have been implemented within suitable time periods
- For each product, maintain a Product Quality Profile, as registered with the regulatory authorities, and provide to the CMO's Qualified Person (QP) so that product can be manufactured, controlled and released in compliance with the Marketing Authorisation
- Take responsibility for one or more of the Quality System(s)
- Provide cover, as necessary, for other QA departmental activities
- A Life Science degree or equivalent
- A broad experience of working within the pharmaceutical industry of which several years will have been operating in a senior QA Management position at a manufacturing site.
- At least 3-5 year experience working in a QA Specialist Role related to different types of pharmaceutical formulation types.
- Excellent working knowledge of international GxPs, especially in the interpretation of MHRA and FDA requirements, for the manufacture, control and distribution of commercial product and clinical trial materials
- Sound knowledge of the principles of solid and semi-solid dosage manufacturing processes (tablets, capsules, gels, creams, ointments) and sterile manufacturing (including Biologicals)
- 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, .computerised systems
If this opportunity sounds like it would be the next step in your career, please get in touch as soon as possible!
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