This position is no longer open for applications

QA Officer - £30K-£35K - Pharmaceuticals - 12 Month Contract

East Manchester 

Overalll function of the QA Officer;

• To investigate incidents of manufacturing, processing or laboratory deviations or abnormal occurrences in order to make recommendations about product compliance and consequent release; or to recommend remedial action to ensure abnormal occurrences do not recur.
• To actively participate, co-ordinate and manage the QA input on various project groups relating to GMP areas served by the function.
• To provide QA support for interdepartmental project work relating to the introduction of new products as and when necessary.
• To review and approve validation protocols prior to their introduction as live documents, as well as validation reports as approval for introduction/continued use of critical equipment/processes.
• To write new SOPs for various issues as the need arises, and to advise on GMP/ quality requirements for content of SOPs generated by other departments.
• To generate technical documents such as Product Quality Reviews (PQRs) and Quality Technical Agreements (QTAs) for assessment by the Quality Management Team.
• To review and approve stability protocols prior to the introduction of the stability study as well as stability reports as approval for completion of the stability study.
• To review and approve other types of GMP documentation such as Quality Control Records and Test Procedures, Process Amendments, and to advise on the content of Batch Manufacturing Records and Batch Packaging Records for QP final approval.
• To review existing SOPs covering Quality Assurance procedures on an as and when basis.
• To perform internal audits of various departments and functions as indicated on the audit schedule and prepare the audit report. To carry out external contractors/suppliers audits as required.
• To liaise with clients on routine QA matters, and participate in client audits/visits.
• To provide QA support for the specification, introduction and validation of new process equipment and or procedures.

Specific Skills & Experience; 

• The job holder must be educated to degree level in a science-based subject or demonstrable equivalent experience, with a minimum of 5 years’ experience in the pharmaceutical industry, to include manufacturing/QA/QC. It is desirable that the job holder should be eligible for Qualified Person training.
• A formal auditing qualification is desirable.
• Presentation skills, and the ability to train personnel in quality matters are required
• The job holder should have good report writing, statistical evaluation and effective meeting skills.
• A thorough knowledge of the principles of equipment/ process/ analytical/ cleaning validation is required. The job holder requires a thorough knowledge of engineering, health and safety, QC (chemical and microbiological), production, regulatory and training issues that may impact on their work.
• The job holder requires good computer skills, and must be able to produce structured technically detailed documents using Microsoft Word, Excel etc.

Please apply now to be considered immediately