Qualified Person

Highly Competitive
  1. Contract
  2. Good Manufacturing Practice (GMP)
  3. United Kingdom
Harlow, England
Posting date: 15 Mar 2021

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.

Job Responsibilities

  • 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.

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.