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As Dublin continues to embed itself as Irelands Pharmaceutical capital, we are seeking QA Manager to become part of a $500 million state of the art bio facility.
Located 15 minutes from Dublin Airport and just a short distance from the lively, vibrant, and cultural Irish capital, this leading biopharmaceutical organisation leads the way with state of the art technology on their one of a kind manufacturing facility.
Responsible for supporting the day-to-day audit program. This position will manage the audit process from end-to-end, liaising with all relevant stakeholders across the business to ensure timely scheduling, execution and close-out of the annual audit schedules. The position will ensure that audit metrics are compiled and maintained in order to achieve the required state of compliance. This data feeds into risk assessment activities across the Quality Management System (QMS) and gives senior management visibility into the health of audit activities across site.
- Compilation of annual supplier (both internal and external) risk assessments used to generate to cyclical audit schedule.
- Reviews and risk assesses new and existing supplier audit requests from various business process owners.
- Maintains an up to date global audit schedule and generates periodic metric reports suitable for viewing by and presentation to Senior Management.
- Liaises with contractor and internal auditors to provide adequate detail of and expectations for upcoming audits.
- Manages the initiation, assignment, execution and close-out of all audit observations and related CAPA responses.
- Participates in and performs audits when required.
- Contributes to the further development of the audit function by shaping the clients audit landscape through proposals and innovative solutions.
- Generates and maintains departmental SOPs.
- For internal audits, partners with internal stakeholders to understand the individual department/process requirements, in order to construct meaningful and focused audit agendas.
- Partners with the Supplier Quality group to ensure seamless on-boarding of new suppliers.
- Minimum 2 years pharmaceutical or biotechnology industry experience in a quality function
- Experience coordinating audit programs and participating in audits
- Proficient knowledge of the pharmaceuticals GxP regulations and standards
- Experience with Trackwise, Veeva and use of pivot tables would be an advantage
- Excellent verbal and written communication skills
- Ability to partner with Business Peers with a focus on collaboration and delivering results.
For further information please apply direct!
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta Consultancy Services does not sponsor Visa applications.
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