SRG's client are looking for an experienced Qualified Person (QP) to join them at an exciting time for the business as they continue to expand.

This is a fantastic opportunity for an experienced QP to take on a permanent role with excellent salary and benefits.

The role:

• Undertake the duties of a Qualified Person as defined in Directive 2001/83/EC and Directive 2001/82/EC.
• Influence the quality agenda and support the maintenance of the QMS to ensure it complies with all relevant legislative requirements.

• You will be expected to provide a QP function for licenced ATMPs according to the relevant directives and guidelines.
• You will conduct QP review of executed batch manufacturing records and certify as defined under SI2012/1916 and under the terms of the Company's MIA and MIA(IMP) and relevant regulatory filings (MA, IND, IMPD as applicable).
• Support the process of batch review and release and coordinate with Quality peers performing batch review duties as necessary.

• Working with the Head of Quality and fellow QPs 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.
• Maintain knowledge of current guidelines and regulatory advancement in line with the role for continued professional development.

• Write, review, approve and maintain Quality SOPs applicable to key areas of the PQS as required.

The person:

• Eligible to undertake the duties of Qualified Person as defined in Directive 2001/83/EC and Directive 2001/82/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
• Prior experience in a pharmaceutical manufacturing environment
• Excellent communication and leadership skills

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.