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
2. Responsible for water and pure steam sampling and analysis as per defined schedule.
3. Viable and non-viable monitoring in clean area of microbiology lab as per the defined schedule.
4. Responsible for Media fill vial observations and CCIT testing.
5. Responsible to identify and maintain EM Isolates, operating VITEK-2, isolates trend preparation.
6. Responsible for biological indicator analysis and issuance and other miscellaneous sample/protocol based studies execution.
7. To handle and distribute various samples received for microbiological analysis. To maintain the log book for the same.
8. Responsible for GPT Analysis and culture handling.
9. Responsible to participate in qualification, requalification, area qualification activities.
10. Responsible to co-ordinate with cross functional department personnel for timely completion of qualification / Validation / Re-qualification activity.
11. Responsible for daily monitoring of temperature, differential pressure, relative humidity of clean areas.
12. Verification and approval of temperature records of BOD incubators, deep freezers, walk-in incubators and cooling cabinets.
13. To perform calibration/qualification of instruments/equipment as per pre define schedule
14. EM, tested sample releases and recording, data update in LIMS.
15. Responsible to handle QMS related activities including preparation/revision of standard operating procedures, Investigations, protocol preparations, report preparation.
16. Responsible for reporting any OOS, Deviation to In-charge.
17. To maintain the inventory of microbiological media, log and status labels for all such items and reconciliation record of items / media.
18. Responsible for decontamination of media, cultures and other microbiological waste.
19. Activities shall be performing apart from assigned job responsibilities as per the instructions of concerned HOD/In-charge
Additional Responsibilities:
Education:
Experience:
Specialized Knowledge: Licenses: 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.
Amneal (NASDAQ: AMRX) is rapidly becoming one of the most dynamic, purpose-driven pharmaceutical companies delivering more affordable access to essential medicines. Our family delivers for yours through a robust U.S. generics business, a growing branded business and deepening portfolios in injectables, biosimilars and select international markets. We’ve bolstered our world-class scientific rigor, production capabilities and commercial infrastructure. And we invest substantially in our people through leadership development and employee well-being programs – all so we can deliver even more value. We are Amneal and We make healthy possible.
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