Quality Assurance Manager Salary: £Excellent (Ref 43160) Location: Manchester City Centre
Contract: Permanent
Quality Assurance Manager. c£Negotiable plus benefits. You will be required to manage all quality assurance functions necessary to ensure compliance with good distribution practice guidelines and conditions of the wholesale dealer’s licence; To act as the management representative to ensure compliance with ISO9001:2008; To act as the nominated Responsible Person for the company.
Principle Responsibilities
1. Quality Assurance
- Effectively manage the quality management system to obtain ISO certified accreditation
- Audit suppliers and distributors as required
- Monitor the review timetable for all SOPs in the business to ensure all departments remain compliant with the quality management system and any regulatory requirements
- To act as the management representative to ensure compliance to ISO9001:2008 and have responsibility and authority for the QMS that includes:
- ensuring that processes needed for the quality management system are established, implemented and maintained,
- reporting to management on the performance of the quality management system and any need for improvement, and
- ensuring the promotion of awareness of customer requirements throughout the organization
- and liaise with external parties on matters relating to the quality management system.
- to ensure that the provisions of the licence are observed
- to ensure that the operations do not compromise the quality of medicines
- to oversee audit of the quality system and to carry out independent audits
- to ensure that all personnel are trained in good distribution practice
- to ensure full and prompt cooperation with product licence holders in the event of recalls
- to maintain a personal knowledge of the products traded under the licence and the conditions necessary for their safe storage and distribution.
- to access all areas, sites, stores and records which relate to the licensable activities and regularly review and monitor all such areas, etc. and the standards achieved.
- To focus on the management of licensable activities, the accuracy and quality of records, compliance with established SOPs, the quality of handling and storage equipment and facilities and the standards achieved
2 Responsible Person (RP)
As per Regulation 10(1) of the Medicines for Human Use (Manufacturing, Wholesale dealing and Miscellaneous Amendments) Regulations 2005 to act as RP within the UK, and to have responsibility for safeguarding product users against potential hazards arising from poor distribution practices. Duties to include the following:
To have personal knowledge of the following areas:-
- the relevant provisions of the Medicines Act 1968 as amended and the Medicines for Human Use (MAs, etc) Regulations 1994 (SI 1994/3144) as amended
- Directive 2001/83/EC as amended on the wholesale distribution of medicinal products for human use
- guidelines on GDP of medicinal products for human use (94/C 63/03)
- the conditions of the wholesale dealers licence
- the products traded under the licence and the conditions necessary for their safe storage and distribution
- the categories of persons to who products may be distributed
- To keep appropriate records relating to the discharge of RP duties
To apply : Forward your CV to
register@connections.gb.com or follow the apply link on this site
Please Note: due to the volume of applications being received we can only respond to those offering the relevant experience as outlined in the advert.