An exciting contract opportunity has arisen for a Qualified Person to join a team within Research and Development. You have the critical role of assuring quality and compliance to our patient through medical products.
- Undertake QP responsibilities for certification and release of intermediate and finished IMP in compliance with GMP, Manufacturing Authorisation, Clinical Trial Application and Regulatory requirements.
- Interpretation and communication of GMP regulatory requirements to staff and customers including Investigational Medicinal product specific GMPs
- Review and approval of non conformance including deviations, customer complaints, out of specification investigations
- Review and approval of control documents SOPs quality agreements
- Involvements in internal customer regulatory inspections.
Skills and Requirements
- Must be eligible to act as a QP for Investigational Medicinal Products, as defined by The Medicines for Human Use (Clinical Trials) Regulations 2004 under permanent provisions.
- Experience working with oral solid dosage forms, including capsules and tablet formulations and /or inhalation products including non-sterile liquids and suspensions.
- Strong decision-making skills based on GMP requirements.
- Able to work calmly under pressure in an environment where a range of issues will pull upon your time and where there can be conflicting priorities.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.