Are you an experienced Compliance Officer with experience in operating quality systems in a GMP QA environment?
Job Title: Compliance Officer
Reference No: 237526
Job Type: Permanent
The position is based in the QA compliance team where a number of key activities are performed. These include the management of the batch release system, the non-conformance and CAPA systems to support the manufacturing and testing of pharmaceutical products to GMP, the management of the internal and supplier audit management programmes, the management of QA environmental compliance and the provision of QA oversight of manufacturing and testing facilities.
You will support the product quality manager to provide QA oversight confirming that activities in manufacturing and testing areas are performed to procedures, to GMP requirements, with the appropriate data integrity compliance. The post holder will provide advice to operational areas and may be required to coach staff as required.
You will assist with the review and management of CAPA issues; change control, risk assessments, failure and deviation investigations, follow up of non-conformance's, attend project meetings, reviewing performance of facility suppliers and training of staff. Administrative support for the team, advising and assisting in specific projects and / or operational area is also a requirement of the role.
You will support non-conformance investigations linked to all aspects of manufacturing and testing of Pharmaceutical manufacture. The post holder will review the investigations and provide advice to ensure resolution of the non-conformance's and the implementation of timely CAPAs. The post holder will provide training/advice to staff for the use of the electronic management system.
Qualification - Essential
Educated to degree level or HND in relevant subject (e.g. Microbiology, or a related subject) or a demonstrable equivalent level of experience of working at a similar level in specialist area
Qualification - Desirable
Membership of IQA, RSC, IOB or equivalent
Knowledge and experience - Essential
Experience in operating quality system(s) in a GMP QA environment with proven evidence of encountering a wide range situations.
Proven experience in operating a GMP non-conformance system in a QA environment in a wide range of situations.
Experience of preparing and providing accurate documents and reports in a timely fashion.
Working knowledge of GLP, GCP and other GxPs.
Please apply to Rachel Oliver, Senior Consultant; ,
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