Position: Manager - Microbiology: M. Sc. Microbiology from reputed institute
Qualification : 15 yrs. in Microbiology (in formulation of ophthalmic, injectable products).
Experience
The candidate shall have hands on experience of microbiology related to:
HVAC, Water system and clean rooms Microbiological Analytical Techniques and Method Validation
The candidate shall have sufficient knowledge of:
Various regulatory requirements related to qualifications and validations, specifically US FDA, EU GMP,
Russia GMP, Ukraine GMP and ISO 13485.
Current industry standards for Microbiology. The candidate shall have following competencies:
Have direct exposure to regulatory audits related to Microbiology. Strong technical writing skills.
Micro level Planning and coordination with CFT.
Location : Plant, Nalagarh
KEY FUNCTION/ RESPONSIBILITIES
Responsible for planning and execution of Microbiology Laboratory functions.
Planning and coordination with CFT departments for smooth functioning.
Timely execution of method validations and per regulatory requirements Responsible for the updating and simplification of procedures as per the regulatory requirement.
Responsible for training on Microbiology related topics to the department and CFT.
Responsible to ensure inventory of consumables and other test accessories.
Responsible for preparation of budget both capex and opex.
Responsible for handling of QMS elements (like change control, Event, CAPA, investigation etc.)
Should have sound knowledge of Microbiological Analytical techniques. Should have sound knowledge of HVAC, Water system and clean rooms.
Responsible for maintaining GLP and data integrity.
mail your CV at
adobhal@sentisspharma.com
