API Research Analyst at USV Private Limited, Govandi, Maharashtra

USV Private Limited is hiring an API Research Analyst in Govandi, Maharashtra, under Generics R&D. This USV API Research Analyst job suits pharmacy and chemistry graduates with analytical lab experience. The role requires 2 – 5 years of experience and a postgraduate qualification. The End Date is 29 November 2026.

Job Details

  • Job Reference ID: USV/ARA/1910615
  • Job Title: API Research Analyst
  • Function: Generics R&D
  • Department: Analytical Research Laboratory
  • Sub Org Unit: ARL – API II
  • Company Code: USV Private Limited
  • GRP: USV Private Limited
  • SBU: Generics and Consumer Products R&D
  • Band: Junior Management
  • Grade: L3 (B)
  • Designation: Executive
  • Employment Type: Employee
  • Employee Category: 1006
  • Required Experience: 2 – 5 years
  • Country: India
  • State: Maharashtra
  • Location: Govandi
  • Posted On: 30 October 2026
  • Closing Date: 29 November 2026

Job Description

Role Objective: The primary objective of the Analyst (AR&D) is to perform analytical testing, method development, method validation, and analytical method transfer for pharmaceutical development, routine, initial, and stability batches. The candidate will ensure strict adherence to cGMP guidelines, regulatory standards, and HSE (Health, Safety, and Environment) policies, ensuring reliable analytical data reporting and operational efficiency within the laboratory.

Type of Interaction (Internal): AR&D Supervisor/Manager, QA/QC Team, Regulatory Affairs, Formulation Development (FRD) Team, Maintenance/Engineering Team.

Nature of Interaction (Internal): Daily reporting of testing progress, submission of analytical raw data, escalation of OOS/OOT results, SOP drafting/reviews, instrument calibration/breakdown reporting, and cross-functional project coordination.

Type of Interaction (External): Analytical Instrument Vendors, Service Engineers, External Reference Standard Suppliers, Regulatory Auditors (during inspections).

Nature of Interaction (External): Coordination for instrument servicing, preventive maintenance, calibration support, equipment troubleshooting, and demonstrating cGMP/data integrity compliance during audits.

Key Responsibilities

1. Analytical Testing & Method Execution

  • Conduct analytical testing for routine, initial, stability, and development batches.
  • Perform Analytical Method Development and Validation (AMDV) for tests including Assay, Related Substances, Dissolution, and Particle Size Analysis.
  • Execute Analytical Method Transfer (AMT) protocols and generate reliable analytical data for regulatory deficiency responses and standard generations.
  • Conduct literature surveys to support analytical strategy and troubleshoot testing methodologies.

2. Data Management, Documentation & Reporting

  • Prepare, review, and maintain analytical documentation, including protocols, method validation reports, transfer reports, laboratory notebooks, chromatograms, and calculation sheets.
  • Ensure immediate submission of raw analytical data to supervisors upon completion of testing.
  • Promptly report any abnormalities, out-of-trend (OOT), out-of-specification (OOS), out-of-acceptance criteria (OAC) results, incidents, or deviations.
  • Suggest necessary changes or improvements in analytical methods supported by objective records and evidence.
  • Execute sample disposal procedures following completed analysis according to standard operating procedures.

3. Equipment Calibration, Maintenance & Compliance

  • Perform routine calibration of laboratory instruments (e.g., HPLC, Dissolution apparatus, Particle Size Analyzers) and update instrument status boards and logbooks.
  • Perform HPLC column regeneration as required.
  • Report instrument breakdowns immediately and maintain complete records of service and repair logs.
  • Ensure accurate entries in logbooks for the usage of innovator samples, in-house reference standards, working standards, and Pharmacopoeial standards.
  • Draft, update, and adhere strictly to Standard Operating Procedures (SOPs).

4. Quality, Safety & Continuous Improvement

  • Maintain strict adherence to current Good Manufacturing Practices (cGMP), GLP, and internal HSE guidelines during all laboratory activities.
  • Optimize operational costs through economical usage of chemicals, solvents, and laboratory consumables.
  • Attend all scheduled trainings in accordance with the department training calendar.

Eligibility Criteria

  • 2 to 5 years of hands-on experience in pharmaceutical Analytical Research & Development (AR&D)
  • Experience handling laboratory deviations, OOS, OOT, and incident investigations.
  • Educational Qualification: M.Sc. in Organic / Analytical / General Chemistry, or B.Pharm / M.Pharm from a recognized university.
  • Certifications (Preferred): Good Laboratory Practice (GLP) or cGMP compliance training certifications.

Required Skills

  • Proficiency in handling analytical techniques and instrumentation: HPLC, UPLC, GC, Dissolution Test Apparatus, UV-Vis Spectrophotometer, Particle Size Analyzer, etc.
  • Practical expertise in method development, validation, and transfer for Assay, Related Substances, and Dissolution.
  • In-depth understanding of cGMP, GLP, ICH guidelines, and data integrity principles.
  • Strong technical writing skills for SOPs, protocols, and validation reports.
  • High analytical accuracy with a focus on eliminating personal/methodological errors.
  • Good communication and team collaboration skills.

Additional Information

  • Skill: API Research and Analysis, HPLC
  • Education Specialization: Post Graduate
  • Highest Education: M.Pharm / M.Sc.
  • Working Language: English

CLICK HERE FOR THE ORIGINAL NOTIFICATION / APPLY ONLINE

Applications close on 29 November 2026.