Senior Compliance Specialist & Deputy RP

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About the job

 Do you want to join a fast-growing global pharmaceutical company? 

Invenia Group is partnered with a leading international pharmaceutical company, that is seeking a Senior Compliance Specialist & Deputy 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
  • Preparation, revision, issuance, control of SOPs, Master, control, uncontrolled, obsolete, and distribution and list
  • Identify compliance gaps in the PQS
  • Develop and lead mitigation plans
  • Support new product introductions
  • Support business projects
  • Preparation, revision, issuance, control of SOPs, Master, control, uncontrolled, obsolete, and distribution and list
  • Preparation, review, and approval of technical agreements
  • Management of recalls or dummy recalls and related documentation
  • Ensure training requirements at the affiliate and monitor compliance
  • Support the corporate site in harmonising key policies and procedures
  • Establish quality standards with other members of QA management, QPs, and QA teams
  • Maintains product quality by enforcing quality assurance policies and procedures and GMDP requirements
  • Prepares quality reports by collecting, analysing, and summarizing information and trends
  • Support quality assurance teams by coaching and mentoring
  • Investigation and management of complaints and initiating corrective & preventive actions
  • Ensure review and approval of PQR’s
  • Support day-to-day activities with QPs and support resolution of queries
  • Design/implement/maintain/improve corporate and local PQS at companies
  • As deputy RP;
    • Ensuring the initial and continuous training programmes are implemented and maintained
    • Coordinating and promptly performing any recall operations for medicinal products Ensuring that relevant customer complaints are dealt with effectively
    • Ensuring that suppliers and customers are approved
    • 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.
    • Approving any returns to saleable stock (in liaison with Corporate functions where relevant)
    • Responsible for supporting the importation of products into the Ireland Market.

 What we are looking for: 

We are looking for someone with a BSC (Hons) and an understanding of the roles and responsibilities of an RP. You should have expertise in Pharmaceutical Quality Management systems/processes and be an effective communicator with excellent relationship-building & interpersonal skills.

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.