Senior Manager

Cadila Pharmaceuticals Limited; Ankleshwar; On-site; INR 2,500,000 - 4,200,000; Full time

Job summary

Cadila Pharmaceuticals Limited in Ankleshwar, Gujarat, India, seeks a senior API production leader to oversee day-to-day production across multiple blocks and ensure strict regulatory compliance. You will lead root-cause analyses, CAPAs, and audits while driving continuous improvements in yield, throughput, and resource utilization.

Responsibilities include ensuring batch release in collaboration with QA/QC, adherence to BMRs and SOPs, and maintaining data integrity, EHS and quality system

Qualifications

• Experience leading API production blocks and ensuring batch execution.
• Strong knowledge of cGMP, ICH, USFDA, EU GMP, MHRA, WHO.
• Experience coordinating QA/QC for batch release and deviations.
• Proven ability to drive continuous yield and productivity improvements.

Responsibilities

• Monitor critical production KPIs such as batch cycle time, yield, OEE, right-first-time, and schedule adherence.
• Lead root cause analyses and CAPA implementations.
• Ensure compliance with approved BMRs, SOPs, and process parameters.
• Oversee day-to-day production across API blocks.
• Drive on-time delivery and adherence to schedules.
• Lead audit readiness and support audits.
• Ensure data integrity and EHS compliance.

Skills

People leadership

Root cause analysis

Regulatory compliance

Audit readiness

Data integrity

Production management

Continuous improvement

Job description

Job Description

Monitor critical production KPIs such as batch cycle time, yield, OEE, right-first-time, and schedule adherence.Lead root cause analysis and implementation of corrective and preventive actions.People LeadershipEnsure strict adherence to cGMP, ICH, USFDA, EU GMP, MHRA, WHO, and other applicable regulatory requirements.Coordinate with Quality Assurance and Quality Control teams to ensure timely batch release and closure of deviations, CAPAs, change controls, and investigations.Lead audit readiness activities and support customer, regulatory, and internal audits.Ensure data integrity and compliance with EHS and quality systems.Lead and oversee day-to-day production activities across API manufacturing blocks, including reaction, filtration, centrifugation, drying, micronization, and packing operations.Ensure adherence to production plans to achieve output targets, cycle times, and on-time delivery commitments.Monitor batch execution and ensure compliance with approved Batch Manufacturing Records (BMRs), SOPs, and process parameters.Drive continuous improvements in yield, throughput, productivity, and resource utilization.