Quality Control Officer

Role & responsibilities

• Analytical Testing: Conduct routine/non-routine tests using HPLC, GC, UV-Vis, FTIR, Karl Fischer, and dissolution apparatus.
• Sampling & Release: Perform sampling of raw materials, packing materials, and finished products; issue Certificates of Analysis (CoA).
• Documentation: Maintain accurate records in LIMS/SAP systems, ensuring ALCOA+ compliance.
• Instrument Management: Operate, calibrate, and maintain analytical instruments per SOPs.
• Audit Readiness: Prepare evidence packs and ensure compliance with FDA, EMA, and CDSCO guidelines.
• Safety & Housekeeping: Follow EHS protocols, PPE usage, and maintain laboratory cleanliness.

Preferred candidate profile

• Strong knowledge of GMP/cGMP, ICH Q7Q10 guidelines.

• Hands-on expertise in analytical instrumentation (HPLC, GC, UV-Vis, FTIR).

• Proficiency in documentation systems (LIMS, SAP).

• Ability to conduct root cause analysis and support CAPA.

• Good communication skills for cross-functional coordination with QA, Production, and Regulatory teams.

• B.Sc./M.Sc. in Chemistry, Pharmaceutical Sciences, or related field.

• 25 years of experience in QC within OSD formulation (tablets, capsules, granules).

• Prior exposure to regulatory audits (FDA/WHO/EMA) preferred.