25 Sep
|
V S International
|
Tarapur
25 Sep
V S International
Tarapur
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
Solid 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.
Positive 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.
📌 Quality Control Officer Tarapur
🏢 V S International
📍 Tarapur