Microbiology Lab Technician

2 days ago

Baddi, India ikon remedies Full time

Key Responsibilities

1. Stability Study Management

  • Execute stability studies as per ICH guidelines (Q1A–Q1E) and company protocols.
  • Place, withdraw, and test samples from stability chambers (accelerated, intermediate, and long-term).
  • Perform analysis of stability samples for physical, chemical, and microbiological parameters.
  • Monitor and document environmental conditions of stability chambers.

2. Laboratory Operations

  • Operate analytical instruments (HPLC, GC, UV, FTIR, Dissolution apparatus, etc.) for stability testing.
  • Ensure proper calibration, qualification, and maintenance of instruments.
  • Conduct method validation, method transfer, and analytical troubleshooting related to stability.

3. Documentation & Compliance

  • Prepare and maintain stability protocols, data sheets, logbooks, and reports as per GDP.
  • Prepare stability summary reports for regulatory submissions and internal review.
  • Handle deviations, OOS (Out of Specification), and OOT (Out of Trend) results, and assist in investigation & CAPA implementation.
  • Ensure compliance with cGMP, GLP, WHO, FDA, MHRA, and other regulatory requirements.

4. Audit & Regulatory Support

  • Support internal audits, external inspections, and customer audits.
  • Ensure compliance with data integrity principles (ALCOA+).
  • Provide stability data to Regulatory Affairs, QA, and Product Development teams as required.

5. Safety & Continuous Improvement

  • Follow EHS practices in the laboratory while handling chemicals and solvents.
  • Support improvements in stability study designs to reduce cycle time.
  • Participate in training, method improvement, and implementation of new technologies.

Qualifications & Skills

  • Education: M.Sc. (Chemistry / Analytical Chemistry) / B.Pharm / M.Pharm
  • Experience: 1-2 years in stability studies / QC stability section (pharma industry – OSD, injectables, or APIs).
  • Good knowledge of ICH stability guidelines and regulatory expectations.
  • Hands-on experience with HPLC, GC, UV, Dissolution, and other analytical instruments.
  • Strong documentation and data integrity practices.
  • Ability to analyze trends, identify OOT, and support investigations.
  • Willingness to work in shifts if required.

Job Type: Full-time

Pay: ₹15, ₹25,000.00 per month

Work Location: In person

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