Job Description

Essential Functions:

o o Perform routine analysis of raw materials, intermediates, APIs, in-process samples, stability samples, and other laboratory samples as per approved specifications and methods.


Carry out sampling of raw materials and packing materials in accordance with SOPs. Ensure accurate, timely, and online entry of analytical results in LIMS and relevant documentation systems. Prepare approved/rejected labels for raw materials, intermediates, and packing materials based on analysis outcomes. Conduct daily verification/calibration of analytical instruments (e.g., pH meter, balance) as per approved methods. Maintain analytical instruments in good condition and ensure logbook entries are updated regularly. Perform LIMS entries and maintain relevant analytical records for traceability and compliance. Participate in investigations related to OOS, OOT, deviations, incidents, and laboratory errors. Ensure compliance with Good Laboratory Practices (GLP), Good Documentation Practices (GDP), and cGMP requirements in all activities. Ensure daily laboratory housekeeping and maintain laboratory safety protocols, including use of PPE. Support review and archival of analytical records and raw data as per data integrity norms. Carry out any other assignments allocated by the QC Head or Designee.

Additional Responsibilities:

Assist in method verification, validation, and transfer activities as required. Support review and revision of SOPs, specifications, and analytical methods. Participate in internal and external audits by providing relevant data and documents. Train junior analysts and contract staff in safe and compliant lab practices. Ensure proper retention, reconciliation, and disposal of samples as per SOPs. Support trending and analysis of analytical data (e.g., stability trends, impurity profiles). Coordinate with production and QA teams to ensure timely testing and batch release. Highlight any instrument malfunctions or quality concerns to the supervisor promptly.

Qualifications

:-

Education:

M.Sc - Chemistry / Organic Chemistry - Preferred B.Pharm / M.Pharm - Acceptable for API QC with strong analytical background

Experience:

4 to 8 years of relevant experience in Quality Control - exclusively in API manufacturing environment

Skills:

Analysis of API, RM, Intermediate Samples - Intermediate to Advanced Instrumental Analysis (HPLC, GC, UV, KF, IR, etc.) - Intermediate LIMS Operation and Data Entry - Intermediate Handling and Review of Analytical Documentation - Intermediate OOS/OOT/Deviation Investigation Participation - Intermediate Good Laboratory Practices (GLP) - Advanced Good Documentation Practices (GDP) - Advanced Laboratory Safety and Compliance - Intermediate Data Integrity Principles - Advanced cGMP Awareness Specific to API Environment - Advanced.

Qualifications

:-

Education:

M.Sc - Chemistry / Organic Chemistry - Preferred * B.Pharm / M.Pharm - Acceptable for API QC with strong analytical background