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
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