Job Purpose:
To perform sampling and analysis of raw materials (RM), packaging materials (PM), and water samples strictly as per approved specifications and procedures, ensuring compliance with GMP and supporting timely material release.
Key Responsibilities
:
Perform sampling of raw materials (RM), packaging materials (PM), and water systems as per approved sampling procedures.
Conduct analysis of RM and PM as per specifications, including identification, physical, and chemical tests applicable to materials.
Perform routine water analysis (e.g., purified water, potable water) as per defined specifications and standard test methods.
Execute tests such as identification (FTIR/UV/chemical), loss on drying, pH, conductivity, and other applicable tests specific to RM/PM/Water.
Ensure proper labeling, handling, and storage of RM/PM/Water samples during sampling and analysis.
Maintain accurate raw data, analytical records, and worksheets related strictly to RM/PM/Water activities.
Ensure timely completion of sampling and analysis to support material approval and production requirements.
Follow approved SOPs, STPs, and specifications applicable to RM/PM/Water without deviation.
Ensure adherence to data integrity principles (ALCOA+) in all RM/PM/Water-related activities.
Identify and report OOS (Out of Specification) and OOT (Out of Trend) results observed during RM/PM/Water analysis.
Maintain cleanliness, safety, and discipline in sampling and laboratory areas related to RM/PM/Water.
Qualifications:
B.Sc. / Msc. / B.Pharm
Experience:
0–2 years of experience in a pharmaceutical company (OSD preferred).