The purpose of this job is to carry out routine monitoring on all water systems on site, product testing and Environmental Monitoring. Also, this job will ensure that the lab is operating in an “inspection ready” status.
Support senior microbiologist in the following lab management activities:
- Ensure compliance in all aspects of the microbiology laboratory eg. Equipment calibration/Qualification, documentation, purchasing, training, regulatory inspections, staffing and compliance
- Ensure all quality reports are written each quarter.
- Ensure lab support for Drug Product Intermediate (DPI) campaigns.
- Provide support for engineering and production on all microbiology issues as required.
- Prepare laboratory for regulatory inspections.
- Ensure compliance in all routine water systems, environmental monitoring, DPI products, non-sterile API production at Cork.
- Ensure CAPA close out in a timely manner.
- Ensure Lab spend is within budget.
- Purchase of all lab supplies.
- Ensure all laboratory equipment is calibrated and validated as required.
- Provide training as necessary to operators on working with purified water systems.
- Ensure Lab is compliant with all relevant QMS GQP,s and GQG’s.
- Responsible for technical change approvals for the microbiology laboratory.
- Co-ordination of reference materials for the laboratory.
- Routine water system testing, and reporting.
- Environmental monitoring testing and reporting.
- Product testing and reporting – non-sterile API and IPC samples from the DPI Facility.
- Compressed Gas Testing and Reporting.
- Agar preparation and QC.
- Ensure lab equipment is in calibration.
- Ensure training is complete for all new analysts.
- Support the Operations and Engineering Team on new water systems and modifications to existing systems.
- Ensure Lab is operated in cGMP compliant fashion.
- Provide Training to cross functional teams as requested.
- Product testing as required.
Decision making Responsibility
- Ability to use risk analysis tools to perform micro risk assessments on plant/processes.
- Problem Solving
- Ability to use OE tools such as RCAs to solve OOS/Lab investigations. Also, be able to participate in cross functional investigation teams.
Environmental Health & Safety (EHS)
- Perform duties in a compliant manner and behave in accordance with site SOP’s, company EHS standards and guidelines and relevant legal requirements
- Read and understand Standard Operation Procedures applicable to role
- Report all accidents, incidents and any EHS issues using the appropriate process /system to your line manager or, if required, the Occupational Health Advisor.
- Maintain work area in an inspection ready state and clean as you go to maintain good safe housekeeping standards.
- Be aware of the impact of your job activities on EHS issues
- Perform duties in a compliant manner and behave in accordance with our Quality Management System requirements.
- Participate fully in our site’s quality initiatives and ensure that all relevant quality standards are adhered to.
- Maintain GMP standards where appropriate to your role
- Read and understand relevant Standard Operating Procedures and Global Quality documents applicable to role
- Management Policies relevant to job role.
- Attend training and complete assessments as required.
- A minimum of a science degree
- A good knowledge of microbiology techniques is essential.
- Good communication/presentation skills
- Good technical report writing skills
- Validation concepts
- Ability to interact with many teams
- At least 3 years’ experience in the pharmaceutical industry.
For a confidential discussion and more information on the role, please contact Aisling on 021 4809118 or email firstname.lastname@example.org
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