Description
JOB DESCRIPTION
Responsible to perform sterility testing, bacterial endotoxins testing, LBPC and bioburden testing of raw material, in-process, packing material, finished products, Stability samples and other miscellaneous samples
- Responsible for water and pure steam sampling and analysis as per defined schedule.
- Viable and non-viable monitoring in clean area of microbiology lab as per the defined schedule.
- Responsible for Media fill vial observations and CCIT testing.
- Responsible to identify and maintain EM Isolates, operating VITEK-2, isolates trend preparation.
- Responsible for biological indicator analysis and issuance and other miscellaneous sample/protocol based studies execution.
- To handle and distribute various samples received for microbiological analysis. To maintain the log book for the same.
- Responsible for GPT Analysis and culture handling.
- Responsible to participate in qualification, requalification, area qualification activities.
- Responsible to co-ordinate with cross functional department personnel for timely completion of qualification / Validation / Re-qualification activity.
- Responsible for daily monitoring of temperature, differential pressure, relative humidity of clean areas.
- Verification and approval of temperature records of BOD incubators, deep freezers, walk-in incubators and cooling cabinets.
- To perform calibration/qualification of instruments/equipment as per pre define schedule
- EM, tested sample releases and recording, data update in LIMS.
- Responsible to handle QMS related activities including preparation/revision of standard operating procedures, Investigations, protocol preparations, report preparation.
- Responsible for reporting any OOS, Deviation to In-charge.
- To maintain the inventory of microbiological media, log and status labels for all such items and reconciliation record of items / media.
- Responsible for decontamination of media, cultures and other microbiological waste.
- Activities shall be performing apart from assigned job responsibilities as per the instructions of concerned HOD/In-charge
Additional Responsibilities
QUALIFICATIONS
Education
- B. Pharm B. Pharm - Required
- M. Pharm M. Pharm - Preferred
Experience:
- 5 years or more in 5 - 8 Years
Specialized Knowledge: Licenses:
About Us
Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.
About The Team
The
Human Resources team partners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs.
Key Roles That The Human Resources Team Performs
Executive Role: Specialists in all aspects of people management. High-level input at strategic level into all key business decisions.
Audit Role: Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures.
Facilitator Role: Close partnership to support, advise and extend the ability of all areas of the organization to meet their objectives through implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing.
Consultancy Role: Provide expert advice to the organization and it's managers on any aspect of workforce management and employee relations and performance.
Service Role: Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market.
