Qc Manager - Injectables

Kilitch Drugs; Khopoli, Pen; On-site; INR 600,000 - 1,100,000; Full time

Job summary

Kilitch Drugs is seeking a QC lead to manage all QC activities for injectable products, including stability testing, finish goods, and IP analysis. You will review analytical results and QC documents to ensure compliance with GMP/GLP and regulatory standards.

You will coordinate with QA and Production for batch release, lead the QC team, ensure timely testing, and support audits with effective closure of observations.

Qualifications

• Experience in QC of injectable products.
• Strong documentation and record-keeping skills.
• Ability to coordinate with QA/Production and support audits.

Responsibilities

• Manage QC activities for injectable products including RM/PM, IP, finished goods and stability testing.
• Review analytical results and QC documents, ensure data integrity and compliance.
• Handle OOS/OOT, deviations, CAPA and investigations; ensure GMP/GLP and regulatory compliance.

Skills

Quality control

GMP

GLP

Documentation

Tools

Calibration instruments

Job description

Manage QC activities for injectable products, including RM/PM, IP, finished & stability testing. Review analytical results and QC documents. Handle OOS/OOT, deviations, CAPA & investigations. Ensure GMP, GLP & regulatory compliance.

Required Candidate profile

• Ensure QC instrument calibration 7 qualification.
• Coordinate with QA/Production for batch release.
• Lead QC team, ensure timely testing and documentation, & support audits and closure of observations.