Telephone: 086 8395533
QA Compliance Officer
Our client, a medical device company in Galway is currently looking to recruit an QA Compliance Officer for their site.
To assist in the process of maintaining compliance to Product Licences / Marketing authorisations
- Conduct Routine Quality Audits of the facility to ensure compliance, be proactive in resolving issues which may arise.
- Set up and maintain the Internal Audit schedule and ensure its completion as per schedule.
- Prepare and conduct annual GMP training programme for the site.
- Approval of Compliance documents e.g. Deviations, SCARS and CAPAs.
- Conduct External audits and compile External Audit reports and lead the collation of responses.
- Management and assistance with the site change control system.
- Handling of customer complaints.
- Provide technical support to the MAH for New Product Introductions and existing Products.
- Review/lead Process investigations and ensure any such investigations are documented appropriately with relevant corrective actions, if necessary.
- Ensure Process transfer is documented and conducted in accordance with Regulatory Standards.
- Quality review and approval of RMWO’s & RPWO’s
- Provision/Updating of existing Quality Procedures in line with issues as they arise as result of validation in cooperation with the appropriate department.
- Contributing to the overall improvement of the company from a Quality/GMP perspective with an emphasis on continuous improvement of the quality system.
- Maintenance of records for the company KPIs as per Quality management review requirements.
- Ensure timely feedback on customer/production queries as appropriate.
- Preparing product quality review reports
- Assist in trouble-shooting product problems.
- Any other duties assigned by the Director of Quality.
- Degree in Science discipline or equivalent.
- Minimum of 3 years Quality Assurance experience within the pharmaceutical industry B.Sc. degree as a minimum requirement.
- Strong organisational skills / ability to prioritize work
- Proven track record as a team player.
- Excellent communication and presentation skills with a hands-on approach
For further information on this QA Compliance Officer role in Galway please contact Bimi on 086 8395533 / email@example.com
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