- Our company is a major force in the pharma and medical devices market throughout Ireland and the UK.
- We sell, market and distribute an innovative and generic range of medical devices and pharma products in areas such as wound-care, urology, procedure packs, critical care (anesthesia, endovascular, cardiology, and IV access), diagnostics, orthopedics and neurology.
- LIP is part of the organisation, and was established in 1977.
- LIP manufactures a full range of high quality prepared microbiological media for both the clinical and industrial markets.
- LIP operates from a modern manufacturing facility, is BS EN ISO 9001:2008 registered and uses the latest technology in media production.
- The facilities include purpose built environmentally controlled areas and cleanrooms that are temperature and humidity monitored to maximize the quality and shelf life of the product. Custom designed high output machines are used in the manufacturing process.
We are currently recruiting for a Quality Control Microbiologist.
Principal Duties and Responsibilities:
- Providing microbiological support to the site
- Ensuring QC meets current Manufacturing Practice (cGMP) requirements.
- Develop, maintain, update and issue microbiological methods, specifications and SOP's in compliance quality and regulatory requirements.
- Audit and review microbiology test results on a daily/monthly/annual basis to ensure compliance with cGMP
- Testing of QC samples provided by the Production facility to ensure compliance with specifications: eg product sterility, pH, Growth promotion recovery, appearance, uniformity, gel strength etc.
- Calibration, maintenance and operation of lab instrumentation, including: pH meter, Spiral plater, Colony counter and Turbidometer.
- Record control and documentation of work performed using laboratory worksheets; documentation must be detailed & accurate.
- Maintenance of controlled organisms (ATCC and NCTC strains).
- Additional routine tests to include
- environmental monitoring of controlled areas,
- process water (bio burden & conductivity)
- product shelf life validation
- temperature monitoring of controlled areas.
- Performing routine laboratory maintenance tasks including organization and cleaning of work areas, waste disposal etc.
- Carrying out investigations on product failures and customer complaints, reporting Non-Conformities and Out of Spec Results to the Quality Control Manager and Production Manager.
- Third level qualification in Microbiology or equivalent.
- Working knowledge of cGMP and ISO standards relevant to Quality Control procedures, documentation and testing. Experience of ISO17025 an advantage.
- Excellent, proven communication skills, both written and verbal with previous experience in drafting and maintaining process document an advantage.
- Attention to detail is essential, with an ability to strictly adhere to methods and SOPs
- Ability to work effectively and co-operatively with others in a fast paced environment.
- Proven ability to cope effectively under pressure and to meet tight deadlines.
- Computer literate.
- Ability to work in a logical, systematic manner
- Excellent written and oral communication skills in English
Contract Type / Other information:
- Permanent role with a competitive salary and benefits package