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Qualified Person (QP)

CY Partners
Job LocationHarlow
EducationNot Mentioned
SalaryCompetitive salary
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypeContract, full-time

Job Description

Qualified Person (QP)An exciting opportunity has arisen for a Qualified Person (QP) to join a global pharmaceutical organisation in the Pharma Supply Quality Assurance group based at their site in Harlow.As a QP, you will have a critical role in assuring quality and compliance to patients through the certification and release of manufactured, assembled or imported investigational medicinal products (IMPs).The main aspects of the role will include:

  • 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 and their interface with GCPs.
  • Review and approval of non-conformance including deviations, customer complaints, out of specification investigations.
  • Review and approval of control documents e.g. SOPs, quality agreements, Packaging records.
  • Involvement in internal, customer, regulatory inspections/audits as required.
    • The successful candidate will 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 is advantageous.This will be a fast-paced role involving the day-to-day release of product batches, and would suit an experienced QP comfortable with the pace of a busy pharmaceutical environment.If this sounds like the role for you, apply now with your CV, and feel free to contact Tom Kirkpatrick at CY Partners for more information. Required skills
  • Certification
  • Quality Assurance

    • Keyskills :
    Certification Quality Assurance

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