Newly created role in a leading pharmaceutical company based in Waterford City.
The purpose of this role:-
- Responsible for quality aspects and support for Inhalation Product Development activities
- QA support for both the Waterford R&D CMC activities and New Jersey Device Development activities.
- Plays a key role in quality management; maintain the quality systems at both sites and ensure compliance with relevant EMA, FDA and other GMP regulations, as well as with corporate policies and standards, in support of GMP manufacturing and testing for Inhalation products.
- QA oversight of vendors supporting development and manufacture of Inhalation products.
- The position includes management of the QA team located at NJ USA.
Responsibilities:
- Final batch release of clinical batches, including review and approval of batch manufacturing records, packaging records, COAs and associated documentation.
- Review and approval of specifications and other relevant CMC documents.
- Review and approval of validation protocols and reports.
- QA oversight of laboratory activities including review of analytical data, protocols and reports.
- Review and approval of change control for changes to systems including facilities, utilities, equipment, laboratory instruments, test methods, raw material, intermediate and finished product.
- Review and approval of investigations, deviation reports, and CAPAs.
The ideal candidate will have Education / Experience
- Professional education in relevant discipline (minimum Bachelor's degree from an accredited Institute in a scientific field, preferably Chemistry)
- Master's degree or PhD preferred
- Experience in a pharmaceutical company.
- Experience in GMP QA.
- Experience in Inhalation products an advantage.
- Managerial experience and capabilities.
- Capable of operating globally.
- Willingness to travel when necessary.
- The position is located at the Waterford, Ireland facility and requires on-site presence to fulfill job requirements and duties.
