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.