Technician I

Responsibilities

• Act as an authorized signer for Batch Manufacturing Records (BMR), BMR Requisitions, and BMR Issuance Logbooks.
• Prepare new BMRs and perform timely revisions to existing documentation.
• Assist in the preparation of Change Controls, Corrective Action Plans, and new equipment documentation.
• Manage and monitor the Environmental Monitoring System (EMS), including reviewing daily reports for action and alert limits.
• Prepare and update SOPs, logbooks, and protocols, ensuring all personnel are trained on updated procedures.
• Execute in-process control instructions as specified in BMR and MBMR to ensure GMP compliance.
• Conduct risk assessments, Failure Mode Effect Analysis (FMEA), and prepare process validation protocols.
• Maintain daily production reports and monitor machine utilization.

Requirements

• B. Pharma degree.
• 7 to 10 years of relevant experience in pharmaceutical operations.
• Strong knowledge of GMP compliance and SOP updation.
• Proven experience in BMR preparation and handling corrective/preventive actions.
• Ability to perform risk assessments and process performance qualifications.

About the Company

Sun Pharmaceutical Industries Ltd is a leading global pharmaceutical company dedicated to providing high-quality, affordable medicines through innovation and excellence in manufacturing.