Manufacturing Process Specialist is a key role in ensuring the quality and safety of pharmaceutical products. The ideal candidate will have a primary degree in Microbiology/Science discipline and a minimum of 5 years' experience within the Pharmaceutical Industry or relevant experience as a Microbiologist.
Aseptic Manufacturing Facility Operations involve routine manufacturing operations, isolator operations, autoclave operations, gamma irradiation, CIP (Clean In Place) and SIP (Steam In Place). The successful candidate will support these operations and be responsible for microbiological testing associated with API testing.
The Role requires close collaboration with QC Micro Team Lead and the ability to make decisions in relation to investigations, site practices, training etc. Strong analytical skills and knowledge of industry regulations including those of FDA, HPRA, EMEA and other authorities applicable to pharmaceuticals and aseptic products are essential. Additionally, experience with project groups or leading teams, Microbiological technologies and methods, analytical techniques such as sterility testing, bioburden and endotoxin techniques are required.
This position offers an exciting opportunity to work closely with cross-functional teams and contribute to the development and implementation of quality systems that meet regulatory requirements. The successful candidate will be proactive in identifying and driving lab process improvements and will possess excellent communication skills to present technical analytical data clearly and concisely to customers, internal investigations and regulatory inspectors.
Below are some of the key responsibilities for this role:
* Support QC Micro Team leader on day-to-day testing operations.
* Perform Data and QC Investigations review and approval.
* Reviews Specifications and plans for associated LIMS scheduling.
* Reviews and approves Nonconformances, CAPA's and Change Control records.
* Plans and oversees lab related projects.
* Proactively identifies and drives lab process improvements.
* Trains laboratory team on specific microbiological technology.