Senior Quality Manager

Job Description

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 amanufacturing/importationauthorisation. 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 sound interpretation of guidelines, legislation, and regulations.
• Review and approve batch manufacturing record templates, batch packaging record templates, finished product specifications, analytical procedures, process validation protocols and reports, hold time study protocols and reports, ensuring compliance with marketing authorisation contents, structure, and production/quality documentation standards.
• Approve change controls, assess suitability, determine required actions, and develop SMART action plans. Monitor change control progression and liaise with Regulatory Affairs, Pharmacovigilance, and Operations departments as needed.
• Prepare deviations, quality risk assessments, root cause analyses, and CAPAs, applying ICHQ9 risk-based principles.
• Approve APQRs, manage the APQR schedule, liaise with CMOs, and oversee authoring by personnel, ensuring timely delivery and escalation to QPs if necessary.
• 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 and grow the business through high standards of customer service to ensure satisfaction.
• Maintain operational and system processes that are customer-focused, efficient, and compliant with policies and legislation.

Key knowledge and skills required for the role:

• Minimum 5+ years’ experience within the pharmaceutical industry.
• Background in quality and manufacturing.
• Ability to perform responsibilities listed.
• IT literacy (proficient with computers and M365 applications).
• Strong and concise writing skills.
• Good communication and organisational skills.
• Ability to manage oneself and others.
• Willingness to introduce new ideas and drive continuous improvement within the company's quality culture.

The Ideal Candidate

We are proud to be a diverse and inclusive employer. We support applicants with specific requirements, whether it's accessibility needs or part-time positions. We aim to find roles that suit individual needs and are happy to make reasonable adjustments during our recruitment process.

Please note that due to high application volumes, we may not provide individual outcomes to all applicants. If you do not hear from us within 28 days, you have been unsuccessful.

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