Analytical Testing: Perform routine and non-routine testing of raw materials, intermediates, drug substances/products, packaging materials, and complaint samples.
Stability Programs: Manage sample storage, execute stability testing, and ensure documentation complies with regulatory standards.
Compliance & Documentation: Ensure activities are aligned with cGMP/cGLP, ALCOA+ principles, and data integrity requirements.
Equipment Management: Operate, calibrate, maintain, and qualify laboratory instruments and systems.
HSE & Lab Safety: Follow health, safety, and environmental guidelines; proactively identify and mitigate risks.
Support Investigations: Participate in deviation investigations, CAPAs, and audit readiness.
Collaboration: Work cross-functionally with QA, production, and R&D for continuous improvement and issue resolution.
Requirements :
Diploma or Bachelor's degree in Chemistry, Pharmaceutical Sciences, or related field.
3–6 years of hands-on experience in a GMP pharmaceutical QC lab setting.
Knowledge of analytical techniques such as HPLC, GC, UV, FTIR, etc.
Experience with LIMS and other quality systems (preferred).
Strong understanding of regulatory requirements (FDA, EMA, ICH).