Quality Manager and Responsible Person
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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 Responsibility
• Ensuring that a quality management system is implemented and maintained.
• Management of authorized activities and the accuracy and quality of records.
• Ensuring that initial and continuous GDP/GMP training programmes are implemented and maintained.
• Coordinating and promptly performing any recall operations for medicinal products.
• Management of outsourced 3rd party relationships and activities
• Management of Quality assistants to complete all Quality related tasks
• Promoting a positive Quality culture within the organisation
• Hosting and supporting MHRA and 3rd party inspection activity
• Management and completion of self-inspection activity
• Support and management of Qualification and Validation activity
• Preparation, support and attendance of Quality management and Product Quality reviews
• Management and investigation of Product Quality complaints
• Acting as Responsible Person as defined regulation 45 of the Human Medicines Regulations 2012 and EU Directive 2013/C 343/01
Desirable:
• 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:
• Management of change within the organisation, risk assessing and mitigating potential Quality impacts as the business grows and develops
• Senior stakeholder management and support
• 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:
• Cogent Gold standard RP training certification
• A minimum of 2 years experience in a GxP Quality role, preferably dealing with the applicable licensed activity of the Bestway Healthcare organisation
• Previous experience as an RP on a wholesale dealers license
• Experience managing other Quality colleagues
• 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
Well 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.
Package Description
- Competitive package
- Excellent training & development opportunities
- Paid Holidays
- Workplace pension scheme
- Staff Discount
- Travel Loans and more...
About the Company
For over 70 years, we've been looking after the health and wellbeing of communities across the UK. Well Pharmacy (part of Bestway Healthcare) is the second largest pharmacy chain in the UK with c.760 pharmacies and a team of around 7,000 colleagues based across our Community Pharmacies, Online Pharmacy, Healthcare Services Centre, Community Drivers, Bestway Medhub & Wardles team and our Support Centre team.
Our mission is to be here for the wellbeing of our patients and customers, to provide the best community pharmacy experience in the UK for everyone, for our patients, our customers, our people, and our NHS.
The pharmacy of the future will look very different from the one we know today. It will play a huge role in transforming primary healthcare and we will play a central role in bringing it to life.
We will use our clinical expertise and technological ambition to take advantage of the potential this future has to offer us. Making medicines, advice, services and care available in the places and spaces that people need and want it most.
We want to be a great business. To be recognised as delivering a community pharmacy experience that is the best there is. To do this we want our teams to feel proud about the positive impact they make, feel valued as part of a close-knit and expert community, and feel confident in their role in a business that is stable, innovative, and caring.
'Together we make a difference'