OverviewQualified Person (QP) Permanent or Contract ideally office based but part home based may also be considered Competitive Salary Innovative cell therapy company based in...
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.