Pharmaceuticals

QA Specialist

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About the job

Do you have expertise in Pharmaceutical Quality Management systems/processes? Do you want to join a fast-growing global pharmaceutical company? 

Invenia Group is partnered with a global pharmaceutical business, searching for a QA Specialist to join their Ireland division. This is a fantastic opportunity to join one of the fastest-growing pharmaceutical companies in the world, where you can be a part of a forward-thinking team of professionals and join a dynamic team and company.

Roles and responsibilities:

If successful, you will be responsible for the following:

  • Compliance reviews for the company and its affiliates, by reviewing records, procedures, and policies against the latest GMDP guidelines
  • Ensuring that a quality system is implemented and maintained encompassing the organizational structure, procedures, processes, and resources/
  • That all critical steps of distribution processes and significant changes are justified and where relevant validated
  • Identify compliance gaps in the PQS
  • Develop and lead mitigation plans
  • Support new product introductions
  • Support business projects
  • Preparation, review, and approval of technical agreements
  • Support the corporate site in harmonising key policies and procedures
  • Prepares quality reports by collecting, analysing, and summarizing information and trends
  • Support quality assurance teams by coaching and mentoring
  • Perform audits of CMOs supporting the affiliate
  • Perform self-inspections and maintain compliance
  • Ensure review and approval of PQR’s
  • The control and review of any outsourced activities related to the procurement, holding, supply, or export of medicinal products
  • These processes should incorporate quality risk management
  • Supporting all operations in Pharmaceutical Wholesale Warehouse (GDP) returned goods management
  • Ensuring the initial and continuous training programmes are implemented and maintained
  • Deal with customer complaints
  • Ensuring the self-inspections are performed at appropriate regular intervals following a prearranged programmes and necessary corrective measures are put in place
  • Taking decisions for the final disposition of returned, rejected, recalled, or falsified products
  • Responsible for supporting the importation of products into the Ireland Market

What we are looking for: 

We are looking for an effective communicator with excellent relationship building & interpersonal skills. You should have strong analytical, problem-solving & organizational abilities, as well as an understanding of the roles and responsibilities of an RP and expertise in Pharmaceutical Quality Management systems/processes. 

Sound interesting? If you are interested in proceeding with this opportunity, please apply so we can arrange a confidential discussion to discuss the position in more detail.