Collins McNicholas

Responsibilities:

  • Lead the QP & QA Operations group (once in place), including batch release, product performance, Data Analytics, new products introduction (NPI), and interface with HPRA and FDA.
  • Ensure product manufacture is in accordance with Good Manufacturing Practice and meets requirements of our patients, Regulatory Authorities (FDA, HPRA etc) and of the company
  • Partner with internal and external Regulatory groups, FDA, HPRA etc while liaising with operations, technical operations, science & technology teams in relation to product filing support.
  • Have responsibility for the oversight of product performance process, product quality Review, complaints and product track and trend
  • Ensure compliance with all processes and procedures while maintaining the Quality Risk Management (QRM) program on site
  • Have knowledge and experience up to date on market and product (technical and scientific) progress and changes in regulations and quality management related to our range of products.
  • In this role, you will act as the primary delegate to the Quality Director and regularly interact with the Senior Management Team.
  • NPI is key to the growth of our business.  As the Senior QA Product Manager, you will support the effective transfer of NPIs to site and into commercial manufacturing; coordinating with external global teams including, but not limited to S&T, Regulatory and CMC QA.
  • You will empower your team to ensure any deviations or planned changes in production or quality control have been addressed according to all relevant regulatory requirements and polices and procedures.   As Lead, you will mentor and coach your QPs, building their technical expertise.
  • Through your team, you will ensure all the necessary checks and tests are performed, including any additional sampling, inspection, tests or checks initiated because of deviations or planned changes while ensuring quality control documentation is completed and endorsed.

Requirements:

  • Third level qualification in a relevant science discipline with minimum 5 years’ experience in the pharmaceutical industry
  • MSc in Industrial Pharmaceutical Science or similar course recognized by Regulatory Authority to permit Qualified Person (QP) status as per Article 49 of Directive 2001/83/EC
  • Minimum 5 years industrial experience gained in an FDA and EMA approved pharmaceutical environment.
  • Minimum 3 years’ experience in an aseptic sterile fill finish manufacturing environment

For a confidential discussion please contact Mark Whelan on 071 914 2411 or email mark.whelan@collinsmcnicholas.ie

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