Title:  Senior Executive - Quality Control

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.