ADL Officer

Analytical Method Development

• Develop and optimize analytical methods for APIs, intermediates, finished products, and related materials.
• Evaluate analytical techniques such as HPLC, GC, dissolution, UV, KF, etc., as applicable.
• Perform method optimization and establish method suitability for intended purpose.
• Prepare analytical method development reports and supporting scientific documentation.

Analytical Method Validation (AMV)

• Plan and execute analytical method validation activities as per approved protocols.
• Evaluate validation parameters, as applicable:
• Specificity
• Accuracy
• Precision / Intermediate Precision
• Linearity and Range
• Robustness
• LOD / LOQ
• Solution stability
• System suitability
• Prepare and review AMV protocols, worksheets, raw data, calculations, and validation reports.
• Investigate atypical results, deviations, and OOS/OOT results associated with validation activities.

Analytical Method Verification / Transfer

• Execute analytical method verification and method transfer activities.
• Support receiving laboratory and transferring laboratory during method transfer.
• Review comparative analytical data and prepare method transfer/verification documentation.

Documentation & Data Integrity

• Prepare, review, and maintain analytical development and validation documentation.
• Ensure ALCOA+ principles and applicable data-integrity requirements are followed.
• Maintain laboratory notebooks, raw data, chromatograms, calculations, worksheets, protocols, reports, and supporting records.
• Ensure proper documentation of deviations, investigations, CAPA, change controls, and laboratory incidents.
• Review analytical documentation for completeness, accuracy, traceability, and compliance.
• Ensure controlled documents are used and obsolete versions are appropriately managed.

Laboratory Compliance

• Follow GMP, GLP, SOPs, pharmacopoeial requirements, and applicable regulatory guidelines.
• Ensure instruments are operated, calibrated, and maintained as per approved procedures.
• Support analytical instrument qualification and troubleshooting activities.
• Participate in internal, customer, and regulatory audits as requiredDocumentation Skills

The candidate should be able to independently prepare/review:

• Analytical Method Development Protocol/Report
• Analytical Method Validation Protocol/Report
• Analytical Method Verification Protocol/Report
• Analytical Method Transfer Protocol/Report
• Analytical procedures and test methods
• Specifications and analytical worksheets
• Validation summary and statistical evaluation
• Deviation and laboratory investigation reports
• OOS/OOT investigation documentation
• Change control and CAPA documentation
• SOPs, STPs, protocols, reports, and controlled laboratory records

Pay: ₹200,000.00 - ₹400,000.00 per year

Work Location: In person