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Quality Assurance Officer

Job Description:

Job Title: Quality Assurance Officer
Location: Bridgend
Department: Quality
Work Pattern: 40 Hours per week
Reporting to: QA Manager
Responsible for (staff): N/A

To perform a Quality Assurance role which supports:

  • Certification and release of medicinal products in accordance with regulatory, Company and project requirements.
  • Maintain, support and improve the Pharmaceutical Quality System employed within PCI.

Essential Duties and Responsibilities:

  • Support the QP in execution of their legal and operational duties.
  • Administer, control and support core systems within the Pharmaceutical Quality system as allocated by line manager. Including but not limited to Internal audits, vendor management, deviations/complaints, Corrective and Preventative Action (CAPA), change control and document control.
  • Reporting of metrics for systems within scope of responsibility.
  • Support and host client audits of the PCI Bridgend facility.
  • Support delivery of site/departmental projects and objectives.
  • Support continuous improvement, validation and technical services activities.
  • Author standard operating procedures.
  • Deliver internal QA and Good Manufacturing Practice (GMP) related training.

Requirements:

Regulatory/Industry Responsibilities:

General

  • Pre-certification assessment of batch records and generation of draft QP certificates.
  • Post QP certification batch release via the inventory system.
  • Review and approval of offsite shelf life extension labelling activities.
  • Pre-approval assessment of change controls and deviations.
  • Co-ordinate and perform investigations into internal and external quality issues.
  • Assess temperature excursions during shipment in line with the stability profile of the product(s).
  • Approval of completed investigations, CAPA’s and change controls.
  • Schedule, perform and close out internal and external audits within established timelines.
  • Pre-review of validation/qualification protocols.

Qualifications:

Required

  • HNC, HND or degree (or equivalent) in a life sciences subject or suitable experience in a Quality Assurance or technical role within the pharmaceutical industry.
  • Experience in a Quality role within a regulated industry (pharmaceutical, clinical, biotechnology or medical device).
  • Experience within a regulated industry (pharmaceutical, clinical, biotechnology or medical device).
  • Experience in a Quality Assurance role within an industry with transferable skills.
  • Holds a qualification in a life sciences subject (level 4 or above).

Preferred

  • Good GMP knowledge and experience of EU legislation and guidelines; experience with FDA GMP requirements CFR 210 and 211 other regulatory guidelines preferable.
  • The ability to introduce, co-ordinate, complete and report on projects.
  • A high level of self-motivation is required
  • Able to rationally persuade.
  • Influencing skills

Behavioural Competencies

  • Communication skills – Must be able to communicate at all levels (internally and externally), using different methods and techniques ranging from written reports to formal presentations.
  • Interpersonal skills – Able to form and maintain relationships at all levels is essential. A Quality Officer must be able to effectively convey potential quality issues and offer constructive advice when required.
  • Thinking and decision making – A Quality Officer will often need to make decisions and advise on appropriate courses of action in the event of a Quality incident or to agree appropriate Corrective and Preventative actions. A Quality Officer should be able to consider all relevant aspects and possible repercussions are considered regarding these quality issues.

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