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/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
• Co-ordinate and oversee QA work to personnel in the Pune, India office within the quality department with respect to deliverables
• Preparation and review of SOPs, based on sound interpretation of guidelines, legislation and regulations
• Timely, accurate review of and approval of batch manufacturing record templates, batch packaging record templates, finished product specifications, analytical procedures, process Validation protocols and reports, hold time study protocols and reports. This requires a demonstratable strong understanding of the Marketing Authorisation contents, structure and compliance of production / quality documentation to this
• Approval of change controls, assessing suitability, all required actions and detailing SMART aligned action plans. Continue to monitor the progression of change controls and adapt planning accordingly, liaising closely with the Regulatory Affairs, Pharmacovigilance & Operations departments where required
• Prepare deviations, quality risk assessments, root cause analyses, and CAPAs, applying a thorough understanding of ICHQ9 risk-based principles commensurate with risk
• Approval of APQRs, managing the APQR schedule, liaising with CMOs and overseeing the authoring by personnel. Responsible for delivery on schedule and escalation to QPs as necessary
• Preparation of and presentation during management review meetings, demonstrating quality trends and focusing senior management attention to key issues
• Review of artwork print proofs prior to authorisation of their use in production
• Approval of artwork and labelling (including PILs) for regulatory submissions
Problem solving & Change:
• Self-motivated and target driven
• Develop and build or business by high standards of customer service to ensure customer satisfaction
• Maintain operational and system processes and ways of working which are customer focused, efficient and complaint with policy and legislation
Key knowledge and skills required for the role:
• 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)
• Strong & concise writing skills
• 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.