Sr. Officer / Officer - QC ( Stability Analysis)

GUFIC BIOSCIENCES LIMITED; Indore District, Pithampur; On-site; INR 400,000 - 600,000; Full time

Job summary

GUFIC BIOSCIENCES LIMITED is seeking a stability lab professional to manage sample reception, adherence to GLP, and orderly recording of stability analyses at our Pithampur facility near Indore.

Experience in injectable pharma processes and knowledge of 21 CFR Part 11 are preferred. The role requires shift work and strict adherence to SOPs, with responsibilities spanning from sampling to protocol preparation and data integrity.

Qualifications

• Candidate should be from Pharma - injectable formulation background.
• Should have knowledge of 21 CFR Part 11.

Responsibilities

• 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.

Skills

Pharma - injectable formulation

21 CFR Part 11

Job description

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)