Quality Manager

CK Group are recruiting for a Quality Manager on behalf of a rapidly expanding developer and manufacturer of Active Pharmaceutical Ingredients to be based at their site in Middlesbrough on a permanent basis.

Your Primary Responsibilities will be as follows:

• To lead and manage the operational performance of the Quality Department (both QA and QC functions) ensuring the successful delivery of business strategy, KPI’s and objectives, whilst adhering to regulatory compliance and achieving commercial success
• To be an active member of the site management team representing the quality function and participating in regular meetings and contributing to the overall efficient operation of the business.
• Coordinating, overseeing and supporting the day-to-day running of the department and allocation of work.
• Ensure activities within the department are in line with company policy, best practice and cGMP compliant
• Provide guidance and support to other departments to ensure their compliance to company policy, best practice and cGMP
• Produce results in line with company policy, best practice and cGMP in the desired timeframes as directed by the business and by their line manager
• Facilitate review and approval of change control and deviation records.
• Oversee Quality Assurance activities; document control; implementation of an EQMS system; Microbiology and Analytical functions.
• Management of Drug Master Files in conjunction with Group requirements
• Final product release for products manufactured on site
• Responsible for internal QA audits
• Ensure integration/ alignment of quality systems within group QA/RA
• To support all Validation and Qualification activities at the site.
• Successfully liaise with members of other departments at all levels to resolve any Quality related issues creating a partnership working environment.
• Perform cGMP and Quality related intra- and inter-departmental training.
• Lead and support audits (client, internal, external)
• To instigate and manage projects to ensure the business continues to operate to cGMP.

To be considered for the position, you should have the following skills and experience:

• A thorough knowledge of cGMP and other regulatory requirements.
• Scientific degree (ideally pharmacy, pharmaceutical sciences, biology, chemistry or related).
• Experience of coordinating and participating in regulatory inspections.
• Excellent project management skills.

For more information or to applyfor the position, please contact Sarah Farrow on 0191 3706486 or sfarrow@ckgroup.co.uk.