A Permanent Qualified Person (QP) Opportunity with Excellent Benefits and Salary.
About the Role:
* Undertake the duties of a Qualified Person as defined in relevant regulatory directives, including Batch Certification and Release of drug product.
* Ensure products have been manufactured and tested in accordance with Good Manufacturing Practice (cGMP) and demonstrate compliance with regulatory requirements.
* Work closely with the Quality Director and site management to implement and maintain GMP compliance in line with legislation, company policies, and manufacturing authorizations.
* Maintain product quality and release by enforcing quality assurance policies and procedures, as well as GMP requirements.
* Act as a Subject Matter Expert (SME) to facilitate site compliance with the company's Quality Management Systems and support the Quality Assurance department during inspections.
* Perform external audits, support self-inspection schedules, and stay up-to-date with current guidelines and regulatory advancements.
About You:
* Must be eligible to undertake the duties of a Qualified Person.
* Hold a relevant degree qualification (preferably in Chemistry, Pharmacy, or Biological Science).
* Have experience with FDA, MHRA, EMA, and other regulatory agencies.
* Prior experience in a pharmaceutical manufacturing environment, particularly with commercial and Investigational medicinal products (IMP).
* Experience in steriles, biologics, and advanced therapeutics is beneficial.
* Extensive audit experience and ability to travel for occasional audits.