Sample management and assignment, Review and approval of analytical reports, Management of Microbial laboratory and ensure the compliance with GLP, cGMP and other regulatory requirements.
Job Responsibilities
- Manage the day-to-day functioning of the Microbiology laboratory.
- Coordination with cross-functional department.
- Management and assignment of samples for routine analysis
- Review of various laboratory raw data and to prepare compilation report as per the SOP and method of analysis/specifications.
- Initiation of CCRs for SOP revision and assessment for Specification updation.
- Performs all work in accordance with all established regulatory and compliance and safety requirements.
- Works in a protected manner collaborating as a team member to achieve all outcomes.
- Demonstrate Behaviours that exhibit Apotex organizational values: Collaboration, Courage, Perseverance, and Passion.
Job Requirements
- Minimum Education
- Sc Microbiology or related to Life sciences.
- Knowledge, Skills and Abilities
- Should be proficient in MS office tools
- Should have competent verbal & written communication skills
- Experience of working on online modules / software would be an added advantage
- Knowledge on preparation of various documents like SOP s, Formats, Protocols, Reports, analytical data etc.
- Should possess troubleshooting knowledge on Instruments and analysis.
- Should have well versed knowledge on regulatory guidelines and thorough knowledge on cGMP activities.
- Experience
- Minimum 10 to 12 years of experience
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