Address
Form of workExecute microbiology laboratory activities including sampling and microbiological testing (MLT, Bioburden, Endotoxin, Sterility, PET, etc) of samples {Raw Material (RM), In-process (IP), or Finished Goods (FG), Stability} and reporting results in adherence to GMP norms and timelines.
The incumbent will assure individual compliance with the all concerned regulatory requirements, GxP’s and applicable department programs, including training, documentation, standard operating procedures, and Sun Pharma policies and procedures.
Key responsibilities:
Perform sampling of raw materials and packing materials for microbiological testing.
Bacterial Endotoxin testing of raw material, packing material, in-process, finished and stability samples.
Sterility testing of raw material, packing material, in-process, finished and stability samples.
Test for Microbial Quality of raw material, in-process, finished and stability samples.
Micro testing of water samples.
Perform Antimicrobial efficacy testing.
Qualifi
...Execute microbiology laboratory activities including sampling and microbiological testing (MLT, Bioburden, Endotoxin, Sterility, PET, etc) of samples {Raw Material (RM), In-process (IP), or Finished Goods (FG), Stability} and reporting results in adherence to GMP norms and timelines.
The incumbent will assure individual compliance with the all concerned regulatory requirements, GxP’s and applicable department programs, including training, documentation, standard operating procedures, and Sun Pharma policies and procedures.
Key responsibilities:
Perform sampling of raw materials and packing materials for microbiological testing.
Bacterial Endotoxin testing of raw material, packing material, in-process, finished and stability samples.
Sterility testing of raw material, packing material, in-process, finished and stability samples.
Test for Microbial Quality of raw material, in-process, finished and stability samples.
Micro testing of water samples.
Perform Antimicrobial efficacy testing.
Qualification and Testing of Biological indicators and Depyrogenation samples.
Operation and analysis of Liquid borne particle count test of In-process sample, finish product and Stability sample etc.
Recording the analytical data in raw data sheet/protocol.
Recording of instrument and standards usage in the respective log books/registers.
Ensure compliance to cGMP and safety standards in the Microbiology laboratory & sampling Area.
Identify & report Deviation and OOS.
Ensure integrity, accuracy and adequacy of the analysis performed.
Ensure working area is kept clean.
Follow the EHS policy, laboratory procedures and maintain the compliance to cGMP requirements.
MINIMUM EDUCATION/EXPERIENCE REQUIREMENTS
Microbiology Graduates or Equivalent Fresh Microbiology Graduate
REQUIRED SUCCESS ATTRIBUTE
• Knowledge of GxP’s, cGMP and other regulatory requirements.
• Attention to detail
• Initiative
• Learning Agility
• Compliance
Secondary Success Attributes
• Collaboration
• Effective Communication
• Passion
Roles
Additional responsibilities can be assigned as required
WORKING ENVIRONMENT/PHYSICAL REQUIREMENTS
Incumbent performs work assignments in both normal office and non-aseptic manufacturing/packaging environments. Moderate to loud noise level is common in production rooms. The incumbent must be able to comply with the gowning requirements for entry into controlled non-aseptic manufacturing areas, and wear personal protective equipment as required.
DELEGATION OF RESPONSIBILITY
In the absence of job holder, delegation of responsibility will be as follows:
Upward Delegation – Strategic site responsibilities to higher level
Downward Delegation – Operational responsibilities to direct reports or similar job role
