LSC have a great contract opportunity for a GDP Operations Manager to join a Dublin based Biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that can help patients overcome serious diseases and improve their quality of life.
Position Summary:
The GDP Operations EMEA/ APAC manager is responsible for supporting the maintenance of the Quality Management System for EMEA/APAC. These activities include change control, non-conformance investigation, supporting internal/ corporate and health authority inspections, supply chain projects, compilation of metrics and document management.
Responsibilities:
- Prepare, update, and/or approve procedures in accordance with GMP/ GDP and company requirements
- Manage all documents in accordance with records management procedures and data integrity requirements
- Serve as the Local Process Owner in the execution of QMS activities, compliance initiatives, best practices, and industry standards per implementation strategy
- Monitor deviations, internal and external change controls and CAPAs, standalone actions to ensure progression and timely closure.
- Develop responses to internal audits and ensure appropriate implementation of corrective actions as required
Requirements:
- Bachelor's Degree in a Scientific/ Technical discipline required
- A minimum of 5-8 years' experience in a Quality or compliance role within the Pharmaceutical industry, most specifically in relation GDP.
- Formal certified GDP Training on Good Distribution Practice of Medicinal Products for Human Use
- Up to date knowledge of relevant pharmaceutical legislation and GDP and ability to apply GDP regulations and international guidelines to all aspects of the position.
- Demonstrated knowledge and application of industry regulations as they apply to quality, including those of HPRA, EMEA, FDA and other authorities.
Contact Grainne Hodnett on (021) 47777329 if you have any more questions about this opportunity or apply directly through this advert.
Note: As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 work visa to apply.
