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

📌 ADL Officer (Vadodara)
🏢 Livmore Life Sciences
📍 Vadodara