Biologics represent the cutting-edge of biomedical research, and biosimilars present an enormous opportunity to provide affordable access to these advanced therapies. Biosimilars are intended to increase patients’ access to biologics as they are priced lower than branded, novel biologics and may further lead to the competitive pricing of the original biologic..Biosimilars can ensure a greater and more equitable access to biologic therapies and to healthcare generally. Biosimilars are projected to generate US$290 billion in savings around the world through 2027, according to IQVIA’s Global Use of Medicines Report for 2023.
Vacancy details:
- Department: SENIOR EXECUTIVE
- Qualification: M.Sc.
- Experience Required: 0-4 years
- Salary: ₹Not Disclosed
Job Description: Greeting from Biocon Limited…!!!!
Important Details :
- Location: QC BIOLOGICALS MICROBIOLOGY – India
- Post of date:13/5/2024
- Selection Process: The selection will be on the basis of Interview.
- Mode of Interview: Face To Face Interview
- Interview Rounds of Interview: HR
Role Summary
• Ensuring safety measures are available and followed during execution of all activities
• Adherence to CGLP (current Good Laboratory Practice) and cGMP (Current Good Manufacturing Practices).
• Adherence to Good documentation practices.
• Responsible for maintaining documents in Microbiology department.
• Verification of annexures for its completeness and correctness after completion of activity.
• Maintenance of Media plates and sterile swab stock records.
• Verification and maintaining the plates and annexures inside the area’s as per requirements for smooth environmental monitoring activity function without any interruption.
• Timely escalation and communication to the leads for any delay in activities and any challenges faced while performing the activities
• To execute any other work allocated as per the requirements
• Utility monitoring (Water) analysis and trend analysis for F1-Fill finish facility, M1, M2, INNOCULUM, QC, W20.
• Co-ordinating results to production.
• Planning and execution of utility monitoring program in production area.
• Sample management and sample segregation and related analysis.
• Initiation and Investigation of out of specification/out of trend results, change control, deviations, and incidents.
• Audits- Facing audits and compliance to the observations.
• Plate Incubation, transfer, and enumeration/release activity in Quality control Microbiology.
• Timely updating of ongoing training records and maintaining the same.
• Performing the routine analysis and updating the results in NOVA EM/Utility LIMS, LABWARE
• Responsible for cleaning and maintenance activities of incubators of the microbiology laboratory.
• Ensuring the initiation of the Escalation notification of OOL/OOS and Lab Incidents within timelines i.e. Within 1 working day.
• Sampling and analysis of water samples as per schedule
Key Responsibilities
• Ensuring safety measures are available and followed during execution of all activities
• Adherence to CGLP (current Good Laboratory Practice) and cGMP (Current Good Manufacturing Practices).
• Adherence to Good documentation practices.
• Responsible for maintaining documents in Microbiology department.
• Verification of annexures for its completeness and correctness after completion of activity.
• Maintenance of Media plates and sterile swab stock records.
• Verification and maintaining the plates and annexures inside the area’s as per requirements for smooth environmental monitoring activity function without any interruption.
• Timely escalation and communication to the leads for any delay in activities and any challenges faced while performing the activities
• To execute any other work allocated as per the requirements
• Utility monitoring (Water) analysis and trend analysis for F1-Fill finish facility, M1, M2, INNOCULUM, QC, W20.
• Co-ordinating results to production.
• Planning and execution of utility monitoring program in production area.
• Sample management and sample segregation and related analysis.
• Initiation and Investigation of out of specification/out of trend results, change control, deviations, and incidents.
• Audits- Facing audits and compliance to the observations.
• Plate Incubation, transfer, and enumeration/release activity in Quality control Microbiology.
• Timely updating of ongoing training records and maintaining the same.
• Performing the routine analysis and updating the results in NOVA EM/Utility LIMS, LABWARE
• Responsible for cleaning and maintenance activities of incubators of the microbiology laboratory.
• Ensuring the initiation of the Escalation notification of OOL/OOS and Lab Incidents within timelines i.e. Within 1 working day.
• Sampling and analysis of water samples as per schedule
