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Employer Hartley People
Job Title Senior Quality Assurance Officer
Description

Our client, a pharmaceutical company are looking for a Senior Quality Assurance Officer to join their team. This is an opportunity to join an established company in a challenging and rewarding role with excellent opportunities for personal development.

The Role:

  • To ensure that all work carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
  • Ensure high quality output – Watch over job processes, tasks and work products to ensure freedom from errors, omissions or defects.
  • Initiate action to correct quality problem and notify others of quality issues as appropriate. If a procedure does not exist, devise one, (through the appropriate channels); if a process needs amending, do so through the appropriate channels.
  • To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement. Highlight opportunities for system optimisation to team members.
  • To ensure review of all QC and production batch documentation when required and correctly in order to achieve a high level of customer service and cGMP.
  • To ensure preparation of Submission Documentation in support of licence applications.
  • Mentoring - support company with problem solving and skill development to aid learning and early problem resolution.
  • Ensure that Vendor Management program is adhered to.
  • Ensure that customer/ Contract services Technical Agreements are initiated and maintained.
  • Ensure that all customer requests are dealt with within a reasonable timeframe.
  • Review batch documentation in a comprehensive and timely manner and notify management of any anomalies which could impact the quality, safety of efficacy of a batch.
  • Ensure Self Inspections are completed as per the defined schedule.
  • Participate in outside Inspections (Customer audits / Regulatory inspections).
  • Lead vendor audits of GxP services as required.
  • Ensure requirements of the company Safety Statement are observed and promote a positive safety culture by leading by example.
  • To perform additional team tasks as agreed to support effective running of the Business.

The Person:

  • Qualified to a minimum of degree level, preferably a Science degree incorporating Quality Assurance.
  • Four years’ experience working in a Quality Assurance role in a manufacturing environment an advantage.
  • Lead Auditor qualification an advantage.

Hartley People Recruitment work to the highest ethical standards within our industry and we value the trust that you place in us when you send your CV. We can provide a full consultation in confidence and we guarantee that your CV will not be sent to any of our clients without your prior consent.

For immediate consideration please call Pairic on 051-878813 or email your CV in response to this job posting.

Hartley People also recruit for similar roles such as Analytical Chemist, Quality Control Manager, Quality Control Technician, Quality Assurance Manager, Quality Assurance Technician, New Product Development Manger, Quality Systems Manager, Formulation Scientist, Development Technologist.

Location Waterford, Tipperary, Wexford
Date Added 7 days ago
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