Officer, Quality Control

19 hours ago

Dahej SIR Gujarat India Amneal Full time ₹ 12,00,000 - ₹ 36,00,000 per year
Description

Essential Functions:


•
• 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

Qualifications :-

Education:


• M.Sc – Chemistry / Organic Chemistry – Preferred

• B.Pharm / M.Pharm – Acceptable for API QC with strong analytical background


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