QA Operations Manager
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| Job Type | Permanent |
| Location | Cork |
| Area | Cork, Ireland |
| Sector | Quality |
| Start Date | |
| Advertiser | Darcy Ainscough-Denton |
| Telephone | +353 1 574 6266 |
| Job Ref | 2416 |
| Job Views | 481 |
- 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
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
