Job Opportunity in Pharmaceutical Organization
We are seeking a highly skilled Microbiologist to join our team.
This is an exciting opportunity for someone who is passionate about ensuring the quality and safety of pharmaceutical products.
The role involves all aspects concerning the microbial quality of the product, including process validation, cleaning validation, method validation/transfer, environmental monitoring, critical site utilities & services, aseptic manufacture.
Main Responsibilities:
* Supports QC Micro Team leader on day-to-day testing operations.
* Performs 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, i.e., Method transfer and optimisation, Equipment Qualification etc.
* Proactively identifies and drives lab process improvements.
* Trains laboratory team on specific microbiological technology.
* Provides superior technical support on specific microbiological technology.
* Supports lean initiatives in lab operations, i.e. standard work, level loading, test method execution, documentation updates and equipment qualification etc.
* Presents technical analytical data clearly and concisely to customers, i.e., internal investigations and regulatory inspectors.
* Writes, reviews and approves technical documents e.g. protocols, APRs, specifications, filing documents.
* Keeps abreast of microbiological technology and compliance trends.
* In conjunction with the QC Micro Team Leader, identify, record and resolve any microbiology related product Quality Issues.
* Liaise with other departments in developing & maintaining the site environmental monitoring and critical utilities programmes.
* Support the Aseptic Manufacturing facility including but not limited to routine manufacturing operations, isolator operations, autoclave operations, gamma irradiation, CIP (Clean In Place) and SIP (Steam In Place).
Requirements:
* At least a Primary degree in a Microbiology/Science discipline.
* A minimum of 5 years' experience within the Pharmaceutical Industry or relevant experience as a Microbiologist.
* Demonstrated knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities applicable to pharmaceuticals and aseptic products.
* Experience with Microbiological technologies and methods.
* Expert in a wide variety of analytical techniques including but not limited to sterility testing, bioburden and endotoxin techniques, autoclave, environmental and utilities testing, and gamma irradiation.
* Knowledgeable of FDA/EMEA regulatory requirements.