- Responsible for analysis of IP/FP/,PV, Semifinished products, hold time samples
- Responsible for maintaining compliance and to ensure GLP in lab.
- Responsible for analysis of samples on HPLC/GC etc.
- Responsible to provide request to section head for issuance of AWR and to record analysis related activities
- Responsible to receive samples of FP/IP/inprocess/,holdtime samples and maintain the record.
- Responsible for reconciliation and destruction of laboratory samples.
- Responsible to maintain records for FP/IP/PV/SFG/Holdtime samples
- Responsible for preparation of COAs
- Responsible to maintain individual training record
- Responsible for record details of OOS/OOT/OOC/Incidents and to participate in laboratory investigation.
- Responsible for flushing of HPLC System as per schedule.
- Responsible for execution of qualification of laboratory instruments
- Responsible to maintain documents as per GLP and GMP system
- Responsible to maintain Data Integrity in lab.
Desired Candidate Profile
- Candidate Should be from Pharma - injectable formulation background.
- Should have knowledge of 21 CFR Part 11.