Qualified Person
Found in: beBee jobs GB - 2 weeks ago
Job title: Qualified Person
Salary: £100,000+ Basic plus market leading package
Do you have the skills to fill this role Read the complete details below, and make your application today.
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. ???? ????-
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