Quality Manager and Responsible Person

ZipRecruiter; Redditch; On-site; GBP 40,000 - 70,000; Full time

Job description

Job Description

Overview of the role

The purpose of the role of Quality Manager is to ensure the maintenance, implementation and retention of the GxP licences our business needs to operate. This role would be in support of both our wholesale business and PI manufacturing operation. The RP roles means that the Quality Manager is named on our WDA(H) and has direct and personal accountability with the regulator for our ongoing GxP licences.

Main Responsibilities

1. Ensuring that a quality management system is implemented and maintained.
2. Management of authorized activities and the accuracy and quality of records.
3. Ensuring that initial and continuous GDP/GMP training programmes are implemented and maintained.
4. Coordinating and promptly performing any recall operations for medicinal products.
5. Management of outsourced 3rd party relationships and activities.
6. Management of Quality assistants to complete all Quality related tasks.
7. Promoting a positive Quality culture within the organisation.
8. Hosting and supporting MHRA and 3rd party inspection activity.
9. Management and completion of self-inspection activity.
10. Support and management of Qualification and Validation activity.
11. Preparation, support and attendance of Quality management and Product Quality reviews.
12. Management and investigation of Product Quality complaints.
13. Acting as Responsible Person as defined regulation 45 of the Human Medicines Regulations 2012 and EU Directive 2013/C 343/01.

Desirable:

1. Eligible to act as an RPi on a WDA(H) in line with the requirements of regulation 45AA and 45BB of the Human Medicines Regulations 2012.

Problem solving & change:

1. Management of change within the organisation, risk assessing and mitigating potential Quality impacts as the business grows and develops.
2. Senior stakeholder management and support.
3. Deviation and non-conformance management with a high degree of problem solving and implementation of corrective and preventative measures.

Key knowledge and skills required for the role:

1. Cogent Gold standard RP training certification.
2. A minimum of 2 years experience in a GxP Quality role, preferably dealing with the applicable licensed activity of the Bestway Healthcare organisation.
3. Previous experience as an RP on a wholesale dealers license.
4. Experience managing other Quality colleagues.
5. Proficient in Microsoft word applications and previous experience with e-QMS and e-DMS solutions (e.g. Q-Pulse, Bizzmine, Mastercontrol, MFiles).

The Ideal Candidate

We are proud to be a diverse and inclusive employer. If you have any specific requirements, we'll do everything we can to support you. Whether it is to find a pharmacy that is accessible, or if it is a part time position you are looking for, we can help find the role that is right for you. If you need us to make any reasonable adjustments to our recruitment process, we will be happy to accommodate you.

Please be aware that due to the high number of applications we receive it may not be possible for us to provide an outcome to all applicants. If you are not contacted within 28 days of your submission, unfortunately you will have been unsuccessful.