Responsible Person

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About the job

Do you want to join one of the fastest-growing international pharmaceutical companies in the EMENA region?

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

Role responsibilities:

If successful, you will complete and/or participate in compliance reviews for the company and its affiliates, by reviewing records, procedures, and policies against the latest GMDP guidelines. You will ensure that a quality system is implemented and maintained encompassing the organisational structure, procedures, processes, and resources, as well as the following:

  • Management, coaching, and mentoring of a quality team
  • Identify compliance gaps in the PQS and support other EU affiliates’ 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
  • Ensure training requirements at the affiliate and monitor compliance
  • Support the corporate site in harmonizing 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
  • Control and review any outsourced activities related to the procurement, holding, supply, or export of medicinal products

What we are looking for: 

We are looking for someone with a minimum of a BSC (Hons), and several years of expertise in pharmaceutical quality management systems/processes. You should be an effective communicator with excellent relationship-building and interpersonal skills and have the sheer determination and drive for results.

You should also be able to build effective teams, creating strong morale and spirit within your team.

This is a fantastic opportunity to join a team of technical minds and forward-thinking business professionals looking to make a difference. To find out more information regarding this role, please apply.