Description
Due to new product and company acquisitions one of the world's leading Generic and speciality pharmaceutical company with 4 sites in Ireland are seeking a QP to join their North Dublin manufacturing facility.Day to Day:
- Responsible for product release, the QP must ensure that each batch released is manufactured and tested in accordance with the current EU/FDA GMP Directives and the relevant marketing authorisation.
- The principles and guidelines of GMP as stated in Directive /EC & as interpreted in the EU Guide to GMP have been followed
- Review of documentation from Quality Control, Manufacturing and Packaging operations for release.
- To assess quality related issues and provide direction to relevant departments to allow efficient resolution of these issues.
- To support the implementation of the Operational Excellence Programme on the site by leading and implementing improvements
- The QP will take actions necessary to maintain and extend their technical and professional competence and to ensure that they have a thorough understanding of any new product or process prior to conducting batch release of products manufactured by the company and their subcontractors.
- To act as change agents by gaining support for and driving sustainable improvements to ways of work
- Ensure compliance with all company and legislative health/safety/environmental requirements
- Any other duties as assigned by the Quality Director/QP Manager.
Requirements/Qualifications:
- Third level qualification in a science related discipline
- Qualified Person status
- Strong organizational skills with the ability to multitask and prioritise workload
- Excellent interpersonal and communication skills
- At least 3 years? Experience in Oral Solid Dosage pharmaceutical manufacturing is preferable.
- An understanding of, or exposure to Lean Manufacturing tools and techniques would be an advantage.
- Proficiency in speaking, comprehending, reading and writing English is required / preferred.
Salary and Benefits:
55-70k, Healthcare, Pension, Bonus.
If you are interested in this role please apply below with an up to date CV. Not sure yet? No CV ready? Give me Anna Mooney for more information .