Senior Product QA Manager

2022-07-13 09:40:342049-12-30Team Horizon
Job TypePermanent
LocationSligo
AreaSligoSligoIrelandSligo
SectorQuality
Start Date
AdvertiserDarcy Ainscough-Denton
Telephone+353 1 574 6266
Job Ref2563
Job Views57
Description
Senior Product QA Manager – Team Horizon
 
Team Horizon currently has an exciting opening for a Senior Product QA Manager for our client who are a global leader in the Biopharmaceutical Industry. You will lead the site Product QA group, ensuring that products manufactured meet requirements of end users, Regulatory Authorities and the company. You will also be expected to ensure products   are manufactured in accordance with the relevant marketing authorisation & GMPs. The Senior Manager, Product QA is responsible for ensuring that all products (Commercial and NPI) produced for the client in Ireland are manufactured in compliance with the applicable GMPs, the site and the client’s Quality Systems.
 
Why you should apply:
  • Our client has developed a stand-out culture of innovation, inclusion, and development, and consistently features as a great place to work.
  • The role is generously compensated and attracts a competitive base salary and benefits package.
  • Our client is forward thinking and pride themselves in excellence, both through their people and quality and dedication of customer care teams.
 
What you will bedoing:
  • Managing the QP Team, Regulatory SME and Quality Specialist Teams including batch review & release, product performance, new products introduction (NPI), regulatory support, change management, and customer complaint management. 
  • Ensuring that products manufactured at the client’s Irish facilities meet requirements of end users, Regulatory Authorities and of the company.
  • Ensure the principal manufacturing and testing processes have been validated; account has been taken of the actual production conditions and manufacturing records.
  • Ensure any deviations or planned changes in production or quality control have been authorised by the persons responsible in accordance with a defined system. Any changes requiring variation to the marketing or manufacturing authorisation have been notified to and authorised by the relevant authority.
  • Should maintain their knowledge and experience up to date in the light of technical and scientific progress and changes in quality management relevant to the products they are required to certify.
  • Support all site NPI activities including QMP & change plan review, validation, MIR / recipe and documentation review & approval, review of executed manufactured CTS batches and release of CTS batches. 
  • Management and execution of regulatory requests to support the client’s Global CMC and RA, review of dossiers for submission / questions received. 
  • Management of the Change management process including review of change plans, chair of CRB, QP review & approval of CPs, QA Specialist review & approval of CP tasks. 
  • Management of Product Quality Review Process including review & approval of all PQRs. 
  • Management of site track and trend process for finished product (API & DP) data. 
  • Supports the principles of Perfect Performance
  • Leads the Site Product QA group
  • Provide technical leadership to functional areas and collaborates with key stakeholders
 
What you need to apply:
  • Third level qualification in a science discipline with minimum 5 years’ experience in the healthcare/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.
 
 
 
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Darcy Ainscough-Denton
Recruitment Consultant
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