Senior Executive - Manufacturing Documentation and Compliance

Overview

This role at SUN PHARMA in Alipur, Delhi requires a Senior Executive to manage and ensure compliance in pharmaceutical manufacturing documentation and processes. Candidates should hold a qualification in B.Pharma, M.Pharma, or MSc and must have relevant industry experience.

Principal Duties

• Authorized to sign and verify critical manufacturing documents such as Batch Manufacturing Records (BMR), requisition and issuance logs, protocols, and risk assessments.
• Perform verification checks on finished product logbooks.
• Develop new and update existing BMRs within deadlines to maintain compliance.
• Support the preparation of Change Control documents, Corrective Action Plans, and new equipment documentation.
• Manage corrective and preventive actions to address quality and process issues.
• Ensure adherence to in-process control instructions outlined in BMRs and MBMRs.
• Create and maintain SOPs, logbooks, protocols, and ensure personnel are trained accordingly.
• Oversee and monitor the Environmental Monitoring System (EMS) daily, including report reviews and prompt action on alerts or breakdowns.
• Maintain daily production reports and monitor machine utilization.
• Conduct training sessions for technicians and supervisors on new or revised BMRs to comply with GMP standards.
• Prepare documentation related to process validation such as process performance qualification and study protocols.
• Develop and analyze Failure Mode Effect Analysis and risk assessments for products and processes.
• Participate in functional and cGMP training sessions as scheduled to stay updated with compliance requirements.
• Undertake any additional responsibilities assigned by the department head, contingent upon training completion.

Qualifications and Experience

• Minimum 7 years of relevant professional experience is expected for the Senior Executive level.
• Educational qualification: B.Pharma, M.Pharma, or MSc in a relevant field.