Qualified Person job in Harlow, England

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Job type: Contract

Discipline: Good Manufacturing Practice (GMP)

Location: United Kingdom

This vacancy has now expired. Please see similar roles below...

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.

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