Executive, Quality Control

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 :-

Education:

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