Senior Manager - Quality Control

Drlogy; Ahmedabad District; On-site; INR 1,200,000 - 1,600,000; Full time

Job summary

Drlogy is seeking a Senior Manager - Quality Control in Ahmedabad. This role involves leading stability operations and ensuring compliance with regulatory standards while managing the quality control team for formulation products.

Applicants should have a B.Sc or M.Sc in Chemistry and 15–17 years of experience in quality control stability, emphasizing laboratory leadership, and compliance governance.

Qualifications

• 15–17 years of experience in QC stability and formulation quality systems.
• Experience in regulatory expectations and audit handling.
• Ability to lead laboratory teams effectively.

Responsibilities

• Lead stability management for formulation products across assigned markets.
• Ensure stability protocols and regulatory compliance.
• Monitor stability chambers and equipment compliance.

Skills

Stability management

Regulatory compliance

Quality control

Laboratory leadership

Analytical review

Education

B.Sc / M.Sc Chemistry

Job description

The Senior Manager - Quality Control will lead stability operations, analytical review, compliance governance, stability strategy, regulatory support, and quality control team management for formulation products at Cadila Pharmaceuticals, Ahmedabad. This requires B.Sc / M.Sc Chemistry qualification with 15–17 years of experience in QC stability, formulation quality systems, regulatory expectations, audit handling, and laboratory leadership.

• Lead stability management for formulation products across assigned markets and product portfolios.
• Ensure stability protocols, testing schedules, data review, and reporting comply with regulatory standards.
• Review and approve stability data, trend reports, investigation reports, and quality documents.
• Monitor stability chambers, environmental conditions, excursions, and equipment compliance.
• Lead investigation of stability‑related OOS, OOT, deviations, and product quality concerns.
• Coordinate with QA, QC, regulatory affairs, production, packaging, warehouse, and R&D teams.
• Provide technical guidance for stability commitments, regulatory submissions, and query responses.
• Ensure compliance with ICH stability guidelines, GMP, GLP, GDP, and data integrity principles.
• Review annual product quality review inputs and long‑term stability trend observations.
• Manage team performance, workload distribution, training, and laboratory discipline.
• Support internal audits, regulatory inspections, customer audits, and inspection responses.
• Identify recurring stability trends and lead preventive quality improvement initiatives.
• Approve SOPs, stability protocols, controlled documents, and quality reports as assigned.
• Ensure timely completion of stability testing, documentation, and regulatory commitments.
• Maintain strong inspection readiness and quality culture in the QC stability function.