Responsible Person

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About the job

Do you have several years of expertise in Pharmaceutical Quality Management Systems/processes? Are you keen to join a fast-growing global pharmaceutical company? 

Invenia Group is partnered with a leading international pharmaceutical company, currently seeking an experienced quality professional to take on the role of Responsible Person (RP) for Ireland. 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.

Role responsibilities: 

If successful, you will be responsible for the following:

  • Complete and/or participate in, compliance reviews for the company and its affiliates
  • Ensuring that a quality system is implemented and maintained encompassing the organisational structure, procedures, processes, and resources
  • Management, coaching, and mentoring of a quality team
  • That all critical steps of distribution processes and significant changes are justified and where relevant validated
  • Identify compliance gaps in the PQS and support other EU affiliate’s PQS systems
  • Develop and lead mitigation plans
  • Support new product introductions and business projects
  • Preparation, review, and approval of technical agreements
  • Coordination and promptly performing any recall operations for medicinal products, in liaison with the national competent authority
  • Deciding on the final disposition of returned, rejected, recalled, or falsified products (in liaison with Corporate functions where relevant)
  • Approving any returns to saleable stock (in liaison with Corporate functions where relevant)
  • Ensure training requirements at the affiliate and monitor compliance
  • Support the corporate site in harmonising key policies and procedures
  • Maintains product quality by enforcing quality assurance policies and procedures and GMDP requirements
  • Prepares quality reports by collecting, analysing, and summarizing information and trends
  • Investigation and management of complaints and initiating corrective & preventive actions
  • The control and review of any outsourced activities related to the procurement, holding, supply, or export of medicinal products
  • Ensuring that deviations from established procedures are documented and investigated
  • Ensuring appropriate corrective and preventive actions (CAPAs) are taken to correct deviations and to prevent them in line with the principles of quality risk management.

What we are looking for: 

We are looking for someone with a minimum of BSC (Hons) and several years of expertise in Pharmaceutical Quality Management Systems/processes. You should be an effective communicator with excellent relationship building & interpersonal skills, as well as the following: 

  • Decision quality
  • Looks toward the broadest possible view of an issue/challenge; can think globally and discuss multiple aspects and impacts of issues and project them into the future
  • Drive for results
  • Building effective teams 

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.