Job Description
Key Roles/Responsibilities:
1. Be the Subject Matter Expert (SME) for all Microbiological activities aligned to client projects, Environmental Monitoring of the Facility providing expertise to the Site and clients on Microbiological matters.
2. Manage microbiology procedures, for testing of raw materials, in process products, bulk drug substance, final products and stability products according to defined by SOP's, and protocols and ensure that the QC microbiology team is in compliance with the same.
3. Apply best cGMP work-practices and techniques to manage the testing and release of raw materials, in process products, bulk drug substance, final products and stability products within specification and in accordance with Data Integrity requirements, Annex 11 Computerised Systems and 21CFR part 11 Good Documentation Practices for Electronic Data.
4. Ensure that all QC Microbiology Analysts are appropriately trained and competent in the procedures they are conducting and are in compliance with best cGMP working practices at all times and are up to date with compliance to regulatory guidance and Annex 1.
5. Ensure subcontract of QC Microbiology testing and dispatching to approved suppliers is performed according to defined procedures and in compliance with GMP.
6. Manage on-time reporting according to the defined and trained document management standards including review and verification of microbiology data, identifying adverse trends and microbiological excursions.
7. Immediately escalate and report any deviations to materials, facilities, processes or procedures to the Site Microbiologist.
8. Be accountable for the microbiology laboratories being clean, tidy and well organized and in a state of continuous inspection readiness.
9. Oversee completion of validation and qualification of new equipment, equipment documentation and equipment periodic reviews within the department.
10. Conduct all activities in the most careful and safe manner and in full compliance with ESH requirements.
11. Ensure that at any time equipment, facilities and materials used in the area of responsibility comply with defined standards.
12. Issue, manage and close-out deviations, change controls, OOS or SST investigations and CAPA's in a timely fashion.
13. Identify areas for continuous improvement and escalate those to the Site Microbiologist.
14. Actively contribute to the development and maintenance of an enthusiastic, supportive and collaborative environment within the team-setting.
15. To undertake any other duties as requested by the Site Microbiologist in accordance with company requirements.
Competencies:
1. High level understanding of Microbiological data and technical processes.
2. Efficient communication.
3. Good organisational and delegation skills.
4. Ability to motivate and organise a team.
5. Strong investigational and problem-solving skills.
6. Ability to work to tight and shifting deadlines and prioritise tasks appropriately.
7. Attention to detail and ability to consider the site holistically.
8. Dealing with external and internal clients and meeting deadlines.
9. Ability to prioritise, provide updates to senior management.
Qualifications
Essential Qualifications:
Degree qualified in a Science Discipline is desirable.
Essential Experience:
Experience within a QC Microbiology laboratory working to GMP within a recognised quality system. Experience managing a team of people. Ability to organise and schedule work within a busy laboratory with experience of writing and working to SOP documentation. Extensive Environmental monitoring and associated microbiology experience and knowledge. Experience and knowledge of GMP guidelines and regulatory bodies.
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