.. for payroll, benefits, human resources, and insurance services. • Industry expertise since 1971 • 730,000+ clients in the U.S. and Northern Europe • Pays 1 in 12 U.S. private sector employees • Largest HR company for small to medium-sized businesses • Product development company having products .. read more
Job Description :
1. Lead, manage and direct microbiology laboratory functions and ensure overall compliance of Microbiology function.
2. Ensure the appropriate quality standards and discipline in microbiology department as per cGMP.
3. Direct and ensure the all the personnel followed good microbiology laboratory practices.
4. Participate in customer and regulatory audits and presenting of Microbiology laboratory.
5. Assess and evaluate the best practices in Microbiology laboratory and in aseptic filling area.
6. Developing User Requirement Specifications (URS), procuring, and qualifying laboratory instruments/Equipment’s.
7. Drafting, review, and approval of Standard Operating Procedures (SOPs) and validation/Qualifications protocols of Microbiology.
8. SME in microbiological method validations (BET, MLT, Bioburden, PET, DET, and sterility assurance)
9. Train the subordinates and colleagues for day-to-day activities as well as regulatory requirements.
10. To perform GAP assessment pertaining to updated regulatory guidance.
11. Review and approve change controls, Lab investigations, OOS, OOT, MDD and other QMS.
12. Provide the technical assistance as Microbiology SME for CAPA proposal and effectiveness.
13. Assist and prepare the Opex and Capex requirements.
14. Assess Microbiology team performance and identify development plan for the team members.
15. Review and ensure day-to-day activities and meets target operational timelines.
Qualification : MSc (Microbiology)
Exp: 15 to 17 Yrs
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