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Quality Compliance Officer, Pharmaceutical GDP

Vacancy Title: Quality Compliance Officer, Pharmaceutical GDP
Contract Type: Permanent
Location: Stevenage, Hertfordshire
Industry:
Salary: £35000 - £50000 per annum
REF: J908554_1623224894
Contact Name: Tom Hammond
Contact Email: tom.hammond@russell-taylor.co.uk
Vacancy Published: 6 days ago

Vacancy Description

Quality Compliance Officer, Pharmaceutical GDP

Location: Letchworth (onsite)

Type: Permanent

Hours: Monday - Friday (either 8:30 - 16:30 or 9:00 - 17:00)

Salary: Competitive DOE

Additional: Company pension, discretionary bonus, private healthcare plan, 25 days hol + BH

Our Client, a cash rich SME that are experiencing significant growth at this point and extending their product portfolio; is looking to recruit for an experienced QA professional who will assume responsibility of the QA function/s and play a key role in the continued development of the QMS.

General Job scope: Ensure company GMP and GDP compliance.

This is a desk-based role, with occasional travel. It also requires close working with scientific, manufacturing and medical personnel within the company, its group companies, its suppliers and its contract service providers.

Responsibilities:

  • Maintain the company's Quality Management System.
  • Monitors performance against quality compliance objectives.
  • Maintain schedule of routine GMP and GDP compliance activities.
  • Maintain schedule of routine non-GMP and GDP compliance activities (eg, Home Office licencing).
  • Create and maintains assigned SOPs.
  • Monitor ongoing product supply standards against registered and specified details.
  • Identify compliance gaps and make recommendations for continuous improvement.
  • Support product recalls and stock recoveries.
  • Administer product technical complaints, including progressing their investigation and report.
  • Implement product and process change controls.
  • Implement deviation investigations and CAPA's.
  • Compile periodic product quality review reports in conjunction with contract manufacturers.
  • Compile data for reports and presentations.
  • Maintain currency of European GMP and GDP requirements.
  • Implement changes that arise from either the introduction of new or revised GMP and GDP regulations.
  • Liaise with the client's contract manufacturers and suppliers as required.
  • Liaise with the clients group companies in areas of quality compliance as required.

The person:

A degree level qualification, ideally in the life sciences.

  • Must have worked in a QA role in a Pharmaceutical GDP setting.
  • Experienced in CAPA, OOs, OOt, and QMS management and implementation
  • MHRA hosting/ liaison experience
  • An awareness of European GMP and GDP legislation.
  • Proven organisational and project management skills.
  • IT skills, particularly in relation to using databases and familiarity with commercial software.
  • Strong interpersonal skills, being able to communicate with senior stakeholders and 3rd party companies/ clients (globally).
  • Being able to work independently.

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