Sr. Officer / Officer - QC ( Stability Analysis)

Job Profile:

• Responsible for receiving stability samples as per stability protocol
• Responsible for maintaining compliance and to ensure GLP in lab.
• Responsible to provide request to section head for issuance of AWR and to record analysis related activities
• Responsible for charging of samples in stability chamber with labelling as per SOP.
• Responsible for withdrawal of stability samples as per schedule
• Responsible for execution of stability analysis within the timeframe.
• Responsible for cleaning of stability chambers
• Responsible for daily temperature monitoring of stability chambers
• Responsible for handling of temperature excursions occurred during temperature monitoring
• Responsible for preparation of stability protocols and their approvals
• Responsible for preparation of stability summary sheets
• Responsible for destruction of stability samples
• Responsible for record details of OOS/OOT/OOC/Incidents and to participate in laboratory investigation.
• 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.
• Preferred who can work in a shift and is willing to work at location Pithampur , Near Indore (M.P)

Email Id : hr.indore@guficbio.com