Description:
Our client is a leading Irish Pharmaceutical organisation in the area of Animal Health. Since their inception, over 40 years ago, they have succeeded in manufacturing, registering and marketing a diverse range of products in over 40 countries worldwide. Their products range from sterile injectables, intramammary, anthelmintics, oral powders, premixes and nutritional supplements providing cost-effective superior treatments for a range of conditions.
They are currently looking for a microbiologist to supervise the microbiology department and act as the manager for the unit.
Role/Responsibilities:
- Environmental Monitoring of high-grade pharmaceutical cleanrooms including personnel samples, surface samples, air and particle count testing using excellent aseptic technique, monitoring PMS (Particulate Monitoring System) during production filling process of the batch.
- Work closely with classified cleanroom teams to ensure alignment with best aseptic practices, standard operating procedures, GMP and regulatory requirements.
- Participating in regular cleanroom inspections to promote continuous improvement and compliance.
- Identifying and documenting all deficiencies found during cleanroom inspections and assessing risk to the product.
- Initiating and supporting remediation measures and investigations required in response to the cleanroom inspection findings and environmental monitoring trends.
- Arrange & deliver initial training for personnel working in the classified cleanroom environment.
- Arrange & deliver periodic re-training in line with SOP & regulatory requirements and/or in response to environmental monitoring trends.
- Assisting in the reviewing and compilation of Standard Operation Procedures and other technical documentation in line with current GMP and regulatory requirements.
- Support with the selection and validation of new cleanroom cleaning, disinfectant, cleanroom consumable products e.g., mops, wipes, garments.
- Provide technical support for new and upgraded classified cleanroom facilities and cleanroom equipment.
- Support simplification & efficiency initiatives.
- Room Pressure readings from Differential Pressure Instruments allocated above each classified area, taking re-readings if pressure differential in OOS and take appropriate steps (stop filling or manufacturing product in the areas affected) to avoid contamination to the product.
- Recording of environmental data onto the departmental database system and trending of results, recording a quality event following excursion from an alert or action limit.
- Assisting with investigations into environmental non-conformant results and performing any OOS investigations of the results using the in-house eQMS and suggesting potential CAPA module and propose any resolutions.
- Reading and Verifying Environmental Monitoring Sample Results and water testing for aseptic suites.
- Generate Product Release Reports and filling in Non-Conformance Reports.
- Identification of Microbial Isolates according to GLP
- Performing Gram Stain and Cellular Morphology, Acid Production and Gas Production methods when identifying isolate, checking motility by using the hanging drop method, using "Vietk" or API system for further identification, carrying identification of Fungi and Yeasts
- Sterile testing of finished products and raw materials, growth promotion
- Taking part in annual training in GMP, GLP and Health & Safety Procedures
- Training and managing new members of staff: explaining good aseptic technique, gowning procedures and overall behaviour in classified areas.
- Scheduling tasks on weekends and holiday overtime shifts
- Troubleshoot equipment and monitoring issues.
- Monitoring production operations for compliance with specifications and promptly reported defects.
Education/Experience:
- Educated to at least a degree level in a relevant Science or Engineering related field OR A minimum of 5-7 years relevant experience working as a Microbiologist within a high-grade cleanroom environment.
- Practical experience of good aseptic technique.
- Experience using Microsoft software packages, in particular Microsoft Excel, Word and power point
- Excellent attention to detail and highly organised.
- Excellent written and verbal communication skills.
- Flexibility to work a shift pattern which may incorporate nights and/or weekends