QA Compliance Officer
Our client, a Pharmaceutical 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 Licenses / Marketing authorisations
- Conduct Routine Quality Audits of the facility to ensure compliance with current EU GMP, 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.
- Conduct External audits, compile External Audit reports and manage associated responses.
- Management and assistance with the site change control system.
- Management of the customer complaints system and associated CAPA.
- Provide technical support for new products Introductions and existing Products, ensuring compliance with the registered dossier.
- 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 manufacturing documentation for Chanelle & third party contract manufacturing.
- Provision / Updating of existing Quality Manual Procedures in order to ensure compliance with EU GMP.
- Contributing to the overall improvement of the company from a Quality / GMP perspective with an emphasis on continuous improvement of the quality system.
- Preparation of Key Performance Indicators for the Quality department and also assisting in the 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 schedule and reports for Chanelle and third party contract manufacture products.
- Assist in product investigations and ensuring risk assessment approach is applied.
- Management of the deviation system and associated CAPA’s.
- Collating monthly trends and assisting the Quality Material Review Board meetings.
The Ideal Candidate
- 3rd level Science Degree
- Minimum of 3 years’ quality assurance experience within the pharmaceutical industry.
- Have excellent interpersonal and communications Skills.
- Highly proficient IT Skills to include Microsoft Word, Excel, Outlook, Project.
- Process driven with strong organizational skills and rigorous attention to detail.
- Good communication skills both written and oral.
- Ability to work in cross functional teams
For further information on this QA Compliance Officer please contact Orla Crowley Healy on 086 0449473 / email@example.com
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