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Quality Compliance Specialist

Ref: 75596

  • Negotiable
  • 07 Sep 2021
  • Waterford
  • Permanent

Quality Compliance Specialist - Stability

About the Company

One of the most desirable employers in the South East is seeking an experienced QC or QA professional to manage Stability programs at their diverse manufacturing site. Working as part of a dedicated team in a fast paced but supportive environment you will will take ownership for the planning and management of stability programs, preparing and analysing trend data and ensuring the QC laboratories are maintained in an Always Audit Ready state.

About the Position

This is a 23 month contract role working days Monday to Friday. A competitive salary is on offer along with a full suite of benefits.

Key Responsibilities 

  • Management of stability programs including generation of protocols and reports, sample management, compilation of results and communication to both internal and external stakeholders
  • Trending and statistical analysis of stability and release data for quarterly reports and Product Quality Reviews (PQRs)
  • Management of quality metrics related to deviations, laboratory investigations, CAPAs etc
  • Providing audit support to the QC team including performing routine and pre-audit walkthroughs, assisting SMEs to prepare and coordination of QC requests during audits
  • Reviewing and updating QC procedures and processes to ensure compliance to current and updated requirements and regulations e.g. new or updated pharmacopoeia chapters.

Experience/Requirements 

  • Honours Degree in a relevant Science discipline
  • A minimum of 3 years’ experience in related QC/QA roles
  • Excellent communication skills and ability to work effectively in cross-functional teams
  • Excellent technical writing skills
  • Experience of stability program management preferable
  • Experience in the use of statistical analysis software packages e.g. Minitab an advantage

Remuneration Package

Salary is negotiable depending on experience. Package includes an annual bonus, healthcare and pension.
Contact

For more information on the role or any other Engineering or Life Sciences roles call Nigel on 087 3618142 or email me or click the apply button below.

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