Telephone: 086 8395533
Quality Manager/ QP
Our client, a pharmaceutical company in Mayo is currently looking to recruit a Quality Manager for their site.
The Product Release Manager will hold responsibility for QA activities in support of Unit Dose through the Product Release Function. The role will provide support to the QA/QP Associate Director in addition to the Business Unit Leader in achieving the required goals and objectives; meeting customer requirements and the necessary regulatory requirements as lay down by the FDA, EU and regional Ministries of Health as relevant.
- Act in the capacity of a Qualified Person in accordance with Annex 16, EudraLex, Volume 4 and directive 2001/83/EC to support disposition of the Pharmaceutical Products
- Manages the batch disposition process to ensure timely release of products
- Ensures the batch disposition process maintains compliance with site practices & regulatory requirements
- Support the deviation/ non-conformances/CAPA program
- Support the Change Management program in the Business Unit
- Be a SME for quality records and quality systems, ensuring consistency of records
- Promote technical writing and quality awareness
- Provide Quality support to site projects
- Identify and support aseptic improvements
- Support the Self-Inspection program
- Inspection Management: (Coordinate site GMP inspections; Internal site preparation; pre-audit MOH requests; Response/report compilation & issuance; Post audit commitment management);
- Quality metrics & monthly quality system & Senior Management review and Local Management Review meetings; (Meeting preparation and coordination of post meeting commitments)
- Represent quality at daily & weekly cross functional meetings
- Manage regulatory standard/guidance revision assessments
- Support the site quality plan and ensure plan execution
- Coordinate compliance initiatives
- Support the Site Quality Risk Management Program
- Requires BSc in scientific discipline with minimum 5 years of relevant work experience in pharmaceutical or related industry.
- Education requirements for Qualified Person eligibility
- Experience in aseptic manufacturing and sterilisation processes (example: Filter Sterilisation) is desireable.
- Proficient in MS Office (Word, Excel, Outlook, and PowerPoint)
- Strong Technical writing ability
- Contentious and reliable worker
- Excellent communication and presentation skills both verbal and written, with the ability to engage with a diverse range of individuals across all levels of the organisation.
- Ability to develop a good working relationships across functions
- Ability to understand and articulate quality requirements in a clear, consistent and coherent manner
For further information on this Quality Manager role in Mayo please contact Bimi on 086 8395531 / firstname.lastname@example.org
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