This job is brought to you by Jobs/Redefined, the UK's leading over-50s age inclusive jobs board.
Overview of the role
On offer is the opportunity to take a leading role in the Quality Management System of a 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 EU, and a manufacturing/importation authorisation. Key Pharmaceuticals is part of the Bestway Healthcare Group.
This is a hybrid working role with 3 days in the office, with a mix of 2 days on client visits and working from home.
Main Responsibilities
* Coordinate and oversee QA work for personnel in the Pune, India office within the quality department regarding deliverables.
* Prepare and review SOPs based on guidelines, legislation, and regulations.
* Review and approve batch manufacturing records, batch packaging records, finished product specifications, analytical procedures, process validation protocols and reports, hold time study protocols and reports, demonstrating a strong understanding of marketing authorisations and compliance.
* Approve change controls, assess suitability, plan actions, and monitor progress, liaising with Regulatory Affairs, Pharmacovigilance, & Operations departments as needed.
* Prepare deviations, quality risk assessments, root cause analyses, and CAPAs, applying ICHQ9 risk-based principles.
* Approve APQRs, manage schedules, liaise with CMOs, oversee authoring, and ensure timely delivery.
* Prepare and present management review reports highlighting quality trends and key issues.
* Review artwork print proofs before use in production.
* Approve artwork and labelling, including PILs, for regulatory submissions.
Problem Solving & Change
* Self-motivated and target-driven.
* Develop high standards of customer service to ensure satisfaction.
* Maintain operational processes that are customer-focused, efficient, and compliant with policies and legislation.
Key Knowledge and Skills
* Minimum 5+ years' experience in the pharmaceutical industry.
* Background in quality and manufacturing preferred.
* Ability to perform responsibilities listed above.
* IT literacy, including M365 applications.
* Strong and concise writing skills.
* Good communication and organisational skills.
* Ability to manage oneself and others.
* Willingness to innovate and drive continuous improvement.
The Ideal Candidate
We are proud to be a diverse and inclusive employer. We support applicants with specific requirements, including accessible workplaces or part-time roles. We are happy to make reasonable adjustments during the recruitment process.
Please note that due to high application volumes, it may not be possible to respond to all applicants. If you are not contacted within 28 days, you 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 cared for communities' health across the UK. Well Pharmacy, part of Bestway Healthcare, is the second-largest pharmacy chain with around 760 pharmacies and 7,000 colleagues across various services.
Our mission is to enhance community pharmacy experiences, focusing on patient and customer wellbeing, and transforming primary healthcare with innovative, accessible medicines, advice, and services.
We aim to be a great business, proud of the positive impact our teams make, valued as part of a close-knit community, and confident in our stability, innovation, and caring approach.
'Together we make a difference'
#J-18808-Ljbffr