Role & responsibilities

Lead the overall Quality Control function and ensure compliance with cGMP, GLP, Data Integrity, and Indian regulatory requirements.

- Manage analysis and timely release of Raw Materials, Packaging Materials, In-process Samples, Finished Products, Stability Samples, Water, and Environmental Monitoring samples.
- Drive Quality Management System (QMS) activities including OOS, OOT, Deviations, CAPA, Change Control, Risk Assessment, and SOP lifecycle management.
- Ensure qualification, calibration, validation, troubleshooting, and effective utilization of analytical instruments such as HPLC, GC, UV-Visible Spectrophotometer, Dissolution Apparatus, TOC, ICP, and other QC laboratory equipment.
- Lead laboratory operations, resource planning, laboratory digitalization, cost optimization, productivity improvement, and implementation of continuous improvement initiatives.
- Review analytical data, ensure data integrity, investigate laboratory incidents, and provide technical guidance for complex quality-related issues.
- Successfully lead and represent the QC function during GMP, Regulatory, Customer, Corporate, and Third-Party audits, ensuring timely closure of audit observations.
- Collaborate with QA, Manufacturing, Warehouse, Regulatory Affairs, Engineering, and other cross-functional teams to achieve business objectives and regulatory compliance.
- Develop, mentor, and lead a high-performing QC team by driving performance management, succession planning, technical competency development, and employee engagement.
- Ensure laboratory operations comply with applicable regulatory guidelines and support new product launches, technology transfers, validation,



and commercial manufacturing activities.

Additional Requirements:

- Excellent communication, leadership, and interpersonal skills with the ability to influence and collaborate across functions.
- Proven experience in leading and managing large Quality Control teams in a pharmaceutical manufacturing environment.
- Strong technical expertise in pharmaceutical Quality Control, analytical chemistry, laboratory systems, and modern analytical instrumentation.
- Hands-on experience with computerized laboratory systems such as Empower, LIMS, Chromeleon, SAP, or equivalent platforms will be preferred.
- Thorough understanding of cGMP, GLP, Data Integrity (ALCOA+), ICH guidelines, and applicable Indian regulatory requirements.
- Demonstrated experience in handling GMP, Regulatory, Customer, and Corporate audits with successful inspection outcomes.
- Robust problem-solving, decision-making, investigation, root cause analysis, and CAPA implementation skills.
- Must possess exposure to working in the Indian/Domestic pharmaceutical market and regulated manufacturing environment.

Experience & Qualification:

- Qualification: M.Sc. (Chemistry) or B.Pharm from a recognized university.
- Experience: 18 - 22 years of progressive experience in Quality Control, with significant experience in leading QC operations.
- Must have experience in Oral Solid Dosage (OSD) and Oral Liquid .
- Candidates with prior experience as Head QC, Senior QC Manager, or equivalent leadership role will be preferred.
- Strong exposure to Indian/Domestic pharmaceutical market is mandatory.
- Experience in facing regulatory inspections from Indian authorities and customer audits is essential.

📌 Manager - Quality Control (Pithampur)
🏢 Alembic Pharmaceuticals
📍 Pithampur