QC Head

Key Responsibilities / Essential Functions

1. Quality Control Operations

• Oversee all QC activities for raw materials, intermediates, in-process samples, APIs, and finished products.
• Ensure timely release of materials and products meeting specifications.
• Supervise stability studies, method validations, and analytical troubleshooting.
• Ensure proper functioning, calibration, and qualification of analytical instruments (HPLC, GC, UV, FTIR, LC-MS, etc.).

2. Compliance & Documentation

• Ensure compliance with cGMP, GLP, ICH, WHO, USFDA, MHRA, EU, and other regulatory guidelines.
• Review and approve analytical reports, COAs, SOPs, STPs, protocols, and deviations.
• Maintain data integrity and ensure ALCOA+ principles are followed.
• Handle OOS, OOT, deviations, and ensure timely investigations with CAPA implementation.

3. Leadership & People Management

• Lead, train, and develop QC team members.
• Allocate resources and monitor team performance.
• Build a culture of continuous improvement, safety, and compliance.

4. Audit & Regulatory Support

• Face regulatory and customer audits for QC-related matters.
• Ensure readiness of QC labs for audits at all times.
• Provide support in regulatory submissions and dossier requirements.

5. Cross-Functional Collaboration

• Coordinate with Production, QA, R&D, and Engineering for timely resolution of issues.
• Support technology transfer and analytical method transfers from R&D to QC.

Key Skills & Competencies

• Strong knowledge of analytical techniques (HPLC, GC, Dissolution, Spectroscopy).
• Deep understanding of regulatory guidelines (cGMP, ICH, WHO, USFDA, EMA, MHRA, CDSCO).
• Experience in analytical method validation, stability studies, impurity profiling, and troubleshooting.
• Excellent leadership, problem-solving, and decision-making skills.
• Strong communication and ability to face regulatory inspections.
• Knowledge of LIMS / chromatography software (Empower, ChemStation, etc.) preferred.

Job Type: Full-time

Pay: ₹65,000.00 - ₹85,000.00 per month

Benefits:

• Health insurance
• Leave encashment
• Provident Fund

Work Location: In person