QA Operations Manager

2022-04-27 16:21:062049-12-14Team Horizon
Job TypePermanent
Start Date
AdvertiserDarcy Ainscough-Denton
Telephone+353 1 574 6266
Job Ref2416
Job Views197
QA Operations Manager – Team Horizon
We are currently recruiting a Quality Operations Manager for our client’s manufacturing facility in Cork, Ireland. Reporting to the Quality Director, in this role you will lead, coach and develop a team of Quality Specialists and QPs, supporting the delivery of the Quality strategy onsite and finished product release.
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 highly attractive benefits package.
  • Excellent career progression opportunities.
What you will bedoing:
  • You will lead and co-ordinate the activities of the QA Operations Team
  • Support the site with RCA and investigations, and event management
  • To ensure finished products are produced in accordance with internal and external quality regulations (US, European, ROW GMP’s and applicable regulatory filings.)
  • To ensure a robust system is in place to determine the acceptance or rejection of batches of finished products manufactured on the Cork site or subcontracted.
  • To support Key quality systems such as complaints, PQR’s, investigations, CAPA implementation and support of key site programmes such as Virtus
  • To manage the activities of the QP’s and QA operations group ensuring development of personnel through goals and development plans and 1:1
  • To provide Quality Support for the Site and to contribute to the implementation and maintenance of Quality Assurance actions in compliance with the current GMP regulations.
  • To make visible the run rate of the group to ensure capacity and org models are fit for purpose and efficiencies in BRR process are being realised.
  • Support Approval for all relevant quality documentation through QA Operations.
  • Review & approve of validation protocol & reports, study protocol & reports to support Capital or key site projects as required
  • Making sure that there is stability data to support retest or expiry date, storage conditions
  • Support inspections and audits from external parties (e.g. FDA, HPRA, etc)
  • Participating in internal audits as required
  • Participate in the preparation/review of regulatory dossiers as required
  • Establish and maintain support and key liaison representative with key customers where we manufacture product
What you need to apply:
  • You will have relevant Bsc degree with 5 + years industry experience in a similiar pharma environment
  • Ideally, you will have or been enrolled for further education to meet the requirements for position of Qualified Person as defined in Article 49 Directive 2001/82/EC
  • Demonstrated ability in the leadership, management, and development of a team in a pharmaceutical area so that you can coach and mentor your team effectively
  • Experience of GMP auditing and documentation
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