Senior Quality Assurance Manager/ Responsible Person
Slough, UK
Responsibilities
- To check ALL goods received are not counterfeit medicines, by looking for evidence of tampering or anything suspicious. Check product description, quantities, expiry dates, batch numbers are accurately recorded and match POs
- Checks to be carried out by using pre-prepared template on clipboard per product arrival
- To ensure goods that have been delivered by bona fide suppliers are to a high standard
- Ensure goods that are damaged are returned to the supplier or destroyed by the appropriate contracted company
- Check that goods supplied damaged by BAP to clients are destroyed responsibly by client before issuing a credit note as described in SOP procedures
- For cold chain products ensure goods have been maintained at 2-8°C by checking temp traces and storing them in the RP database, clearly labelled
- Become familiar with BAP eQMS system and keeping it updated, ensure an effective quality system is implemented and maintained
- Lead QMR meetings
- Liaise with Germany and US
- Be completely familiar with BAPs stock control system Orderwise and ensure goods are booked in accurately, print off weekly stock reports and share this with key stakeholders and share any issues or concerns
- Ensure that the conditions of the wholesale dealer’s license are met, and the guidelines of Good Distribution Practice are complied with
- Check that Warehouse and Cold Room temps are kept between the parameters on a daily basis Cold Room 2-8°C, Warehouse 8-25°C
- Ensure SOPs are up to date and reviewed on a regular basis, introducing new ones as needed
- Liaise with the MHRA and Home office as and when necessary. To be present for any visits by the MHRA and/or Home Office
- Liaise with QP for goods arriving from outside the EU
- Check that the temp probes are serviced and calibrated annually and records kept
- Train all employees and ensure they understand the SOPs
- Keep a record and store supplier’s WDL
- To understand the workings of various shippers, e.g. Credos and Sherpa’s so that if there is a temp excursion a rational explanation can be given to the client
- Keep an accurate record on the RP database of all temp traces
- Ensure that the activities of the company are properly reflected in the Wholesale Dealer’s Licence and the provisions of the Wholesale Dealer’s Licence are observed
- Ensure that the operations do not compromise the quality of medicines
- Ensure that adequate records are maintained for a period of 5 years
- Ensure full and prompt cooperation with marketing authorisation holders in the event of recalls
- Oversee audit of the quality system and to carry out independent audits. (Experience in hosting supplier/ client audits and regulatory audits such as MHRA)
- Ensure that appropriate standards of GDP are maintained
- Ensure Technical Agreements are in place and maintained between suppliers and clients and able to demonstrate experience in creating TA’s
- Carry out risk assessments on business/ GDP critical areas and has experience in conducting risk assessments
- Carry out validation exercises on new processes, equipment and changes. Experience in process and basic equipment validation e.g. FMD System
Job Requirements
- Knowledge of The Medicines Act 1968
- Knowledge of Eudralex, The Rules Governing Medicinal Products in the European Union, Volume 4 Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use
- Good Understanding of the Wholesale Dealer’s Licence
- Knowledge of, The Human Medicines Regulations ( UK SI 2012 1916)
- Understanding of Directive 2001/83/EC as amended, of the Community Code relating to medicinal products for human use
- Understanding of, The New Guidelines for Good Distribution Practice of medicinal products for human use
- Knowledge of Commission guidelines for GDP of medicinal products for human use (2013/C68/01)
Competencies
- Attention to detail and thorough
- Concern for Standards
- Excellent communication skills
- Diplomacy with MHRA, Home Office and Clients
- Interpersonal awareness and sensitivity
- Flexible and Adaptable
- Tenacious
Work Conditions
- Reports directly to the Managing Director
- Overtime may be required from time to time to meet project deadlines
- Ability to work under own initiative and as part of a team