Qualified Person - Manchester, United Kingdom - Albion Rye Associates

Description

Job Description

Job title: Qualified Person

Salary: £100,000+ Basic plus market leading package

Site commutable from: Manchester, Liverpool, Blackburn, Burnley, Wigan, Leeds, Huddersfield, Bradford, Halifax & Harrogate.

Albion Rye Associates are working in partnership with a globally recognised market leader in their space to recruit a Qualified Person (QP) for their site in the North of England.

Responsibilities:

• Defining GxP protocols and benchmarks for the facility in conjunction with the divisional Quality unit and external stakeholders, overseeing gap analyses, and spearheading enhancement initiatives as needed.
• Offering Quality guidance to teams working on FMEA, root cause analysis, and other investigative methodologies to ensure a comprehensive and systemic quality ethos permeates all operations.
• Promptly reporting trends and quality concerns uncovered during batch evaluations, systemic anomalies, or operational observations to the Head of Quality.
• Conducting QP batch certification for authorized pharmaceuticals (in accordance with relevant regulations) and delivering QP assistance as necessary for plant-related issues, expert evaluations, annual reviews, and documentation supporting licensure submissions/variations and product clearance.
• Collaborating with Group Regulatory Affairs to provide authoritative GMP counsel for new submissions and modifications/supplements.
• Participating in internal and external audits, and aiding in vendor quality oversight endeavors at both local and divisional tiers.
• Contributing to internal and external inspections by regulatory agencies (UK, US, EU, etc.).

Requirements:

• Eligibility to perform the duties of a Qualified Person
• Extensive background in the pharmaceutical quality sector.
• Comprehensive understanding of approved products, procedures, and regulatory frameworks.
• Prior engagement with MHRA/VMD, FDA, and involvement in regulatory inspections.
• Thorough grasp of global pharmaceutical regulations.

If you are an Eligible QP looking for a new challenge, drop me a message Would be more than happy to discuss more and understand if this could be a good fit for yourself.