Location: Vadodara, Gujarat, India - Category: Quality
Assistant Manager - Microbiology
Assistant Manager – Micro. is responsible to lead microbiology section for the organization. The role holder is responsible for development, validation and maintenance of microbiology related procedures and effective execution of related operational work. The role holder is also responsible for the engagement, growth and retention of team members in microbiology section.
- Technical expert for all micro related questions, issues and decisions in the organization including aseptic techniques and procedures.
- Real time review of documents of micro such as Sterility, MLT(Product/water), BET, Media, EM, Assay, Culture and all other microbial compendial tests performed.
- Review of validation and routine calibration documents of instruments, planning and execution of the same.
- Review and analyze data, generate reports and review / approve work of all microbiology staff.
- Review and approve protocol, SOP, annexure, format, layout design etc.
- Handling of Deviation, Investigation, OOS, OOT, incident and review of same.
- Qualification of instruments and review
- Manpower management, lead & train team and maintain discipline within team.
- Facing regulatory audits and compliance audits
Background & Experience:
- Msc Microbiology/Biotechnology/BPharm/MPharm
- Minimum 10-12 years of relevant experience in microbiology function of Sterile Formulation / Injectables industry with around 5 years of team handling experience.
- Exposure to software-based systems such as EBMS, EQMS, EQCS etc.
- Knowledge of aseptic processing, water system, EDMS.
Truly global work environment.
High performance culture.
Ability to make a difference.
Best in class compensation.