Qualified Person

2 months ago


East Kilbride, South Lanarkshire, United Kingdom Brightwork Limited Full time
About the Role

Brightwork Limited is seeking a highly experienced Qualified Person to join our team in a key role that will play a pivotal part in ensuring the quality, safety, and efficacy of medicinal products.

Key Responsibilities
  1. Batch Certification and Release: Ensure that all medicinal products are manufactured and released in compliance with EU directive 2001/83/EC and Eudralex Volume 4 Annex 16.
  2. Pharmaceutical Quality System Management: Support QA Leadership in the day-to-day management of the Pharmaceutical Quality System (PQS) to ensure compliant life cycle management of products.
  3. Quality Guidance and Support: Provide guidance on quality matters across the business to ensure QA drives continuous improvements and maintains fit for purpose product development and management.
  4. Batch Release Process Management: Manage the batch release process, including management of Locum QPs, organizing release of product, and other activities as required to maintain the manufacturing authorization with the MHRA.
  5. Product Quality, Safety, and Efficacy: Undertake a critical role in upholding the highest standards of product quality, safety, and efficacy.
Requirements

We are looking for a commercially aware and pragmatic individual with a wealth of experience undertaking a company-wide, multiple site Qualified Person role. The ideal candidate will possess highly effective communication skills and be well-versed in working with multiple internal, external, and regulatory stakeholder groups.

This is an excellent opportunity to join a highly innovative organization dedicated to providing a first-class working environment and may be offered on a flexible/hybrid working basis in conjunction with a highly competitive remuneration package.



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