Qualified Person

England  ‐ Onsite

Keywords

Quality Management Good Manufacturing Practices Food Safety Auditing Customer Relationship Management Business Process Improvement Databases Consulting Occupational Safety and Health Recruitment Maintenance Manufacturing Medicines and Healthcare Products Regulatory Agency (MHRA) Guides Regulatory Requirements Wholesaling IT Recruitment Regulatory Affairs Safety Principles

Description

We are seeking an experienced and compliant Qualified Person (QP) to support our pharmaceutical operations, ensuring license maintenance and the effective execution of Critical Control Points (CCP) to uphold our high standards of quality and safety.

Key Responsibilities:

  • License Compliance: Ensure that our site's licenses (e.g., Manufacturing/Import Authorisation, Wholesale Distribution Authorisation) are maintained and aligned with regulatory standards.
  • Batch Release: Perform QP certification and release of medicinal products, ensuring compliance with Good Manufacturing Practice (GMP) and regulatory requirements.
  • CCP Execution: Manage and oversee all Critical Control Points, ensuring effective monitoring and swift response to maintain product safety and integrity.
  • Regulatory Liaison: Act as a point of contact for regulatory authorities, providing support during inspections and audits.
  • Quality Systems Oversight: Ensure that all quality systems and processes meet regulatory standards and drive continuous improvement initiatives.
Requirements:

  • Qualification: Must be a Qualified Person with a proven track record in batch release and quality assurance in line with MHRA standards.
  • Experience: Extensive experience in GMP, quality systems, and regulatory affairs.
  • Skills: Strong analytical and problem-solving skills, attention to detail, and excellent communication abilities.


Darwin Recruitment AG is a Zurich based, SECO licensed, privately owned subsidiary of Darwin Professional Staffing Group Ltd (a Global IT Recruitment Consultancy).

Darwin Recruitment AG manages client relationships whilst also utilising Darwin Professional Staffing Group databases and networks to source Candidates and fulfil client requests.

We do not ask for a placement fee from Candidates/Employees.

If you wish to contact a specialist regarding this role, or your job search in general, please contact
Start date
11.2024
Duration
6 months
(extension possible)
From
Darwin Recruitment
Published at
04.11.2024
Contact person:
Greg King
Project ID:
2813016
Industry
Medicine and Pharmaceuticals
Contract type
Freelance
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