Technical Services Manager
This speciality healthcare company focuses on improving patient’s lives while creating value through developing, manufacturing, marketing, and distributing quality branded pharmaceuticals, generic pharmaceuticals, over the counter medications and device products through its numerous operating companies. Since its foundation in 1997, the company has expanded to include the following business segments: U.S. Branded Pharmaceuticals, U.S. Generic Pharmaceuticals, Devices, and International Pharmaceuticals. Headquartered in Dublin, Ireland, this organisation is rapidly looking to expand its operations here. As a result, a new requirement in the business for a Technical Services Manager has arisen.
The Technical Services Manager will:
- Be the functional subject matter expert responsible for the execution of all product specific technical assessments and equipment capabilities, leading the identification of technical issues, troubleshooting and problem solving.
- Review and where appropriate, sign/approve technical documents (MBRs, MPRs, Protocols, Change Controls) and CMC documents to support development, submission, and on-going manufacture of all assigned products.
- Direct the identification of opportunities for process robustness improvements and process capability improvements at CMOs; leveraging local Technical expertise and working with CMOs functional counter-part to complete specified work.
- Be responsible for technical analysis of product complaints and recommended CAPAs/changes. The Technical Services Manager will also provide detailed and thorough technical assessment, analysis, and recommendation for any manufacturing investigation, as well as Providing Impact Assessment of internal or CMO initiative Change Control.
- BS in Chemical Engineering, Chemistry, Pharmacy or related scientific field with a minimum of 10 years relevant experience in the pharmaceutical industry or related field. Or, an advanced degree with a minimum of 7 years experience.
- Familiarity with cGMP, DEA, and FDA regulations and SUPAC and ICH guidelines. This position requires an understanding and experience with pharmaceutical manufacturing processes and equipment. Experience with various dosage formulations is also required.
- Experience implementing and evaluating contracted work with vendors and suppliers and maintaining successful partnerships.
To learn more apply on line or call Shane Browne on +353 1 6321865.
Salary: On Application
Location: Dublin South