|Salary:||€35000 - €40000 per annum|
|Contact Name:||Rachel Radford|
|Job Published:||December 06, 2016 16:53|
- Carry out all daily duties according to cGMP/cGLP and quality systems in order to meet the agreed master production schedule.
- Ensuring appropriate microbiological testing of submitted samples including, raw material, product, environmental and deionised water samples, ensuring all testing is carried out in an accurate and efficient manner and in-line with all relevant company policies and procedures.
- Execution of testing associated with cleaning validation.
- Highlighting any issues which may lead to failure in quality or failure of product to meet the required specifications.
- Raising and documenting investigations relating to microbiological out of specification results and driving the identification and implementation of agreed CAPAs assigned to the appropriate individuals.
- Scheduling and performing unannounced audits to identify weaknesses in systems and processes such as cleaning, hygiene, equipment, cleaning, garbing and utilities such as the water system. Identify improvements and proactively work with the appropriate groups to implement improvements.
- Training relevant staff in GMP cleaning techniques and good hygiene.
- Proactively support the validation engineers in the protocol development and execution of cleaning validations.
- Development and execution of annual site GMP Training.
- Demonstrating a proactive approach towards identifying issues which may impact the quality of product.
- Revising documentation as required and recommend improvements where appropriate as well as working effectively to build productive relationships with other functional groups within the company.
- Work to key metrics in Health & Safety, Quality/Compliance, Customer Service and cost.
Education and Experience:
- A degree in Microbiology.
- At least three (3) years' experience working within a GMP/GLP environment in a microbiology role.
- One (1) years industrial experience in the QC Micro testing of in vitro diagnostic products.
- Aseptic handling experience.
- Microsoft Office experience, including Word, Excel and Access.
- Understanding of production operations, quality control and cGMP/GLP requirements
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