Overview of the role
On offer is the opportunity to take a leading role in the Quality Management System of a young and rapidly growing pharmaceutical company, Key Pharmaceuticals. The organisation operates as a virtual generics company which holds its own marketing authorisations within the United Kingdom/United Arab Emirates and a manufacturing/importation authorisation. Key Pharmaceuticals is part of the Bestway Healthcare Group, a vertically integrated business.
Main Responsibility
- Manage personnel in the Pune, India office within the quality department with respect to deliverables
- Be accountable for the following processes:
- Review of data for incoming batches prior to and/or following QP certification
- Change Control approvals
- Deviation, CAPA, Quality Risk Assessment preparation and approvals
- Rapid, accurate review of and approval of BMRs, BPRs, FPSs, MoAs, PVPs, PVRs, HTSPs, HTSRs, specifications prior to production
- Support in technology transfer projects
- Approval of artwork and labelling (including PILs) for regulatory submissions
- Review of artwork prior to production (print proofs)
- Be a primary contact person for external contacts (e.g. CMOs, CTLs, other vendors) with respect to quality activities
- Approval of vendors
- Approval of nitrosamine risk assessment, excipient risk assessments, elemental impurities risk assessments, TSE/BSE documentation
- Approval of APQRs
- Management of audit planning and preparations
- Management of Analytical Method Transfers
- Liaising with third-parties for OOS/OOTs
- Preparation of quality technical agreements
- Involvement in Management Review Meetings
- Manage quality aspects related to production planning (e.g. implementation of changes via change control)
- Manage initial handling of complaints and their investigation
- Preparation of and review of SOPs
- Perform MA gap assessments and see changes to the MA through to maintain market supply for new product launches and marketed product
Key Skills and Experience :
- Minimum 5+ years experience within the pharmaceutical industry
- Quality and manufacturing background preferred
- Demonstratable ability to perform responsibilities listed below
- IT literacy (able to use computers easily, M365 suite of applications)
- Good communication and organisation skills
- Ability to manage self and individuals
- Willingness to bring new ideas to the table and drive continuous improvement as part of the company’s quality culture
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 salaries
- 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’
