Mediplacements are recruiting for an experienced and dynamic Quality Assurance Manager in Luton, ideally with GPhC registration but not essential. Our client requires a driven candidate primarily for their Quality Assurance role but who is willing to provide support in the inhouse private pharmacy when required. They are searching for candidates who have an interest in quality assurance/new product development within the world of specials manufacture
The job is available to start ASAP, working pattern will be covering full-time hours Monday - Friday, 09:00-18:00 (40 hour contract)
Company pension - 5% employee contribution and 4% contribution by employer
Life insurance - 4 x annual salary
Annual Leave - 20 days
Bank holidays - 8
Working hours - 09:00-18:00 (40 hour contract)
Onsite car parking - Yes
As Quality Assurance Manager, you will be responsible for leading and managing the strategic operational performance of the quality team. To motivate and guide the quality team on their daily tasks, to co-ordinate with Head of Quality in various decision-making tasks and, to help organise day to day work by allocating tasks to QA officers. Organising periodic meetings with staff and co-operating in meeting with higher management. Additionally, handling deviations, CAPAs, customer complaints, change control etc. you will be responsible to make sure that the business runs smoothly, and tasks are completed within given deadlines.
*To develop and maintain quality department strategies to ensure that they meet business requirements and customer needs.
*To implement and monitor the QMS system to ensure risks are adequately controlled within current requirements.
*To act as the main point of contact for any issues related to quality internally and externally.
*To guide QA officers in their day-to-day tasks such as releasing of products, periodic checks and to perform other quality tasks when needed.
*To make decisions on whether the product is good to release in case of any temperature excursion.
*To approve or reject starting materials such as licenced medicines, unlicenced medicines, and raw material when required.
*To monitor and co-ordinate various validation activities to ensure adherence to the validation plan.
*To approve and review analytical methods, validation methods, equipment qualification methods, equipment cleaning validation methods, protocols and reports.
*To review supplier qualifications.
*To approve customers such as pharmacies, wholesalers, hospitals etc. on the ERP system.
*To perform, oversee, approve, manage, and investigate various QMS tasks such as Deviations, CAPAs, Risk Assessment, Change Control, Customer complain etc.
*To carry out self-inspection every month to identify and resolve any problems in GMP, GDP and documentation.
*To maintain and update the Site Master File when required.
*To perform, mange, and oversee product recalls.
*To perform and document the annual Product Quality Review (PQR).
*To create, update, approve and review product specifications.
*To perform, review, and approve material risk assessment of product when required.
*To revive periodic checks such as microbial testing, control drug testing, and to perform these checks whenever it is required.
*To co-ordinate in various internal and external audits and inspections such as MHRA or Home Office inspections.
*To ensure regulatory compliance is up to date with legislation changes, MHRA and Home Office licenses.
*To ensure quality matrix is up to date.
*To ensure every department is complying with GMP and GDP.
*To maintain awareness between staff about new proposed or implemented legislation that can impact business and to communicate any changes to the Senior Management Team.
*To prepare, update, review and maintain various quality documents such as visual displays, forms, and SOPs
*To prepare, review and approve technical and quality agreements for suppliers, customers, and contracted companies.
*To ensure appropriate investigation of discrepancies, errors, complaints, failures, or adverse reactions which require documentation, if necessary.
*To ensure periodic quality meetings occurs on time.
*To ensure that staff members have good relations and communications between them.
*Investigate and monitor in case of OOS (Out of Specification) & OOT (Out of Trend) results received from contracted QC Lab for bulk batch manufacturing.
If you would like to be considered for this role or require further details, please contact Gerard or Richard @ Mediplacements 0345 230 6666 or firstname.lastname@example.org