Qc Manager

Deccan Nutraceuticals; Alandi; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Deccan Nutraceuticals in Maharashtra, India, is seeking a Quality Control Manager to lead laboratory operations, ensure product quality, and maintain regulatory compliance.

You will oversee testing, stability studies, equipment calibration, data integrity, and audits, while guiding a team of QC analysts.

Responsibilities

• Oversee chemical, biological, and microbiological tests for materials, batches, and finished products.
• Direct shelf-life and environmental stability studies for drug compounds.
• Ensure instruments are calibrated, maintained, and validated for accuracy.
• Enforce GMP; comply with USP/EP and global regulatory expectations.
• Review and approve analytical data, results, and lab documentation.
• Lead responses during internal and external regulatory inspections.
• Lead investigations into OOS/OOT results to identify root causes.
• Develop and implement CAPA to resolve lab discrepancies.
• Oversee transfer, optimization, and validation of analytical methods.
• Train analysts on SOPs, data management, and safety; supervise QC staff.

Job description

Responsibilities of a Quality control Manager

Laboratory Operations & Testing -

• Manage daily testing: Oversee chemical, biological, and microbiological tests for raw materials, intermediate batches, and final products.
• Stability programs: Direct shelf-life and environmental stability studies for drug compounds.
• Equipment oversight: Ensure laboratory instruments are calibrated, maintained, and validated for accurate use.

Compliance & Quality Assurance -

• GMP adherence: Enforce strict compliance with pharmacopeial guidelines (USP, EP) and global regulatory expectations.
• Data integrity: Review and approve analytical data, test results, and laboratory documentation.
• Audit readiness: Lead laboratory responses during internal and external regulatory inspections (such as by the FDA or local drug authorities).

Investigations & Continuous Improvement -

• Out-of-Specification (OOS): Lead investigations into OOS or out-of-trend (OOT) test results to find root causes.
• CAPA execution: Develop and implement corrective and preventive actions (CAPA) to resolve lab discrepancies.
• Method validation: Oversee the transfer, optimization, and validation of analytical testing methods.

Team Leadership -

• Staff training: Train analysts on standard operating procedures (SOPs), data management, and safety protocols.
• Resource management: Supervise QC personnel, assign daily tasks, and evaluate team performance.