Salary £30,000 to £35,000
We are working with a large pharmaceutical company in the North East who are seeking a QA Officer to work in a busy team dealing with quality assurance queries in a GMP environment.
What you’ll do
This role will work around a team of QA Officers (around 7) as well as Documentation Reviewers and QA Apprentices to perform batch sentencing activities, reviews, approvals, audits and maintain operational quality systems.
This will involve using SAP, and looking at controlled intermediates, and finished goods. These cover production and analytical review, deviation and change assessment.
You will be responsible for Operational Qualification (OQ) approvals, approvals to changes in process, analytical and engineering procedures, and ensure any changes are carried out in accordance with relevant product registrations.
You will be performing OQ assessment of decision paths, non conformances and detiations as well as out of calibration / OOS investigations.
The job holder will also review GMP cleanouts and ensure manufacturing isn’t commencing until the documentation and signoffs are satisfactorily cleared.
Regular review of the plant and business area for GMP compliance, as well as identification of relevant corrective actions. Audit, review and monitoring. You will identify corrective actions closed out through the quality audit trail.
Change control, complaints, audit observations, and customer notifications as well as coordination of validation activities will also be central to the role.
You will be a graduate or equivalent in the sciences the area of study is not critical. You may be also qualified via years of experience in the above role. We anticipate for this level of role £30,000+ salary etc that someone will have 5 years or so of experience to take on the full spectrum of responsibilities.
You will have a comprehensive knowledge of cGMP and guidelines applicable to Active Pharmaceutical Ingredient (API) manufacture, quality assurance, laboratory practices and production.
On this occasion, LiCa Scientific is acting as an employment agency.