Officer/Sr. Officer

4 weeks ago

Dahej, India Milan Laboratories Full time

Interested candidates are requested to share their resumes at for interview scheduling on 7th September 2025 at Hotel Ginger, Bharuch. Please note that it is mandatory to pre-schedule the interview before reporting at the venue.

Key Responsibilities:

  • Perform routine and non-routine analysis of raw materials, intermediates, finished products, and stability samples related to SVP.
  • Execute and document activities related to Analytical Method Validation (AMV) and Analytical Method Transfer (AMT) as per approved protocols.
  • Conduct instrument handling, calibration, and troubleshooting for analytical techniques such as HPLC, GC, Dissolution, UV-Vis, FTIR, and other QC instruments.
  • Prepare, review, and maintain analytical test procedures, protocols, and reports in compliance with regulatory requirements.
  • Ensure accurate documentation in laboratory records, logbooks, and LIMS systems in line with data integrity principles.
  • Support regulatory audits and inspections by providing required analytical documents and justifications.
  • Comply with all Good Laboratory Practices (GLP), Good Manufacturing Practices (cGMP), and EHS requirements.
  • Participate in OOS/OOT investigations, deviation handling, and CAPA implementation.
  • Collaborate with cross-functional teams for technology transfer and product scale-up related to SVP formulations.

Key Skills:

  • Analytical Method Validation & Transfer
  • Sterile/Parenteral QC Testing
  • HPLC/GC/UV handling
  • Regulatory & cGMP compliance
  • Documentation & Data Integrity
  • Problem Solving & Investigation Support

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