QUALIFIED PERSON (QP)
SRG's client are looking for an experienced Qualified Person (QP) to join them at an exciting time for the business.This is a fantastic opportunity for an experienced QP.
- Undertake the duties of a Qualified Person as defined in Directive 2001/83/EC.
- Responsibility and performance of Batch Certification and Release of drug product in accordance with requirements of EU Directives and GMP.
- Ensure products have been manufactured and tested in accordance with Good Manufacturing Practice as defined in EU Directive 2003/94/EC.
- Ensure products manufactured demonstrate compliance with the requirements including EU GMP Annex 16 and also appropriate regulatory authorizations.
- Working with the Quality Director and site management to ensure that GMP compliance implemented and maintained in accordance with the appropriate legislation, company policies/procedures and in compliance with appropriate manufacturing authorizations.
- Review and implement Quality Management Systems in compliance with current GMP and any regulatory updates or observation.
- Maintain product quality and release by enforcing quality assurance policies and procedures and GMP requirements.
- Act as a Subject Matter Expert (SME) to facilitate site compliance with the company's Quality Management Systems.
- Support the Quality Assurance department for all compliance inspections of the site e.g. internal audits as well as Regulatory Inspections.
- Perform external audits
- Support the self-inspection schedule for the Company
- Maintain knowledge of current guidelines and regulatory advancement in line with the role for continued professional development.
- Eligible to undertake the duties of Qualified Person as defined in Article 51 of Directive 2001/83/EC
- A relevant degree qualification (preferably in Chemistry, Pharmacy or Biological Science.)
- Experience with FDA, MHRA, EMA and other regulatory agencies.
- Previous Quality Assurance experience
- Excellent communication and leadership skills
- Previous management and supervisory experience
If you meet the above requirements and think this sounds like an interesting opportunity, please apply online or contact Emma.
your application has been submitted