Senior Executive

4 days ago

Dadra and Nagar Haveli, India Sun Pharmaceutical Industries, Inc. Full time ₹ 1,50,000 - ₹ 28,00,000 per year
Title: Senior Executive - Quality Control

Date: Sep 9, 2025

Location: Dadra - Quality Control

Company: Sun Pharmaceutical Industries Ltd

Job Purpose:

To ensure the quality and compliance of raw materials, packaging components, intermediates, and finished products through rigorous testing, documentation, and adherence to cGMP and USFDA guidelines.

Key Responsibilities:
1. Analytical Testing & Review
  • Perform and review analytical tests on raw materials, intermediates, and finished products using instruments like HPLC, GC, UV, IR, KF, etc.
  • Conduct stability studies and method validations.
  • Ensure timely sampling and testing as per pharmacopeial/in-house specifications (IP, BP, USP, Ph. Eur.).
2. Documentation & Data Integrity
  • Maintain accurate records in raw data sheets, COAs, logbooks, and LIMS/SAP systems.
  • Ensure compliance with ALCOA+ principles for data integrity.
  • Prepare and review SOPs, protocols, and other QC documentation.
3. Regulatory Compliance
  • Ensure all QC activities comply with cGMP, GLP, and USFDA requirements.
  • Support in regulatory audits (USFDA, MHRA, WHO-GMP) and internal inspections.
  • Review executed batch records and analytical data for regulatory submissions.
4. Instrument Calibration & Maintenance
  • Ensure proper calibration and upkeep of laboratory instruments.
  • Coordinate with external agencies for instrument validation and troubleshooting.
5. Investigations & CAPA
  • Participate in OOS/OOT investigations and root cause analysis.
  • Implement and monitor CAPA effectiveness.
Qualifications:
  • Education: B.Sc. / M.Sc. / B.Pharma in Chemistry, Pharmaceutical Chemistry, or related field.
  • Experience: 5–10 years in a pharmaceutical QC laboratory, preferably in a USFDA-approved facility.
  • Certifications: Knowledge of ICH guidelines, cGMP, GLP, and regulatory documentation.
Skills Required:
  • Proficiency in analytical techniques and instruments.
  • Strong understanding of regulatory requirements and documentation.
  • Experience with LIMS, SAP, and other QC software systems.
  • Good communication and team collaboration skills.

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