QA Operations Manager
| Job Type | Permanent |
| Location | Cork |
| Area | Cork |
| Sector | Quality |
| Start Date | |
| Advertiser | Darcy Ainscough-Denton |
| Telephone | +353 1 574 6266 |
| Job Ref | 2416 |
| Job Views | 197 |
- Description
- 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
- 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
