Sr Manager - Production (Downstream)

PeopleStrong; North Goa; On-site; INR 800,000 - 1,200,000; Full time

Job summary

PeopleStrong in India is seeking an experienced professional to oversee downstream operations in a cGMP environment. You will coordinate batch scheduling and ensure strict compliance with quality standards.

The role emphasizes cost optimization, data integrity, equipment performance, and cross-functional collaboration with QA/QC, Engineering, Supply Chain, and R&D.

Responsibilities include maintenance, material availability, audit readiness, and adherence to safety and environmental policies.

Responsibilities

• Manage day-to-day downstream operations per cGMP norms.
• Schedule downstream batches and ensure timely execution.
• Reduce costs by evaluating processes and alternate vendor options.
• Analyze repetitive failures and develop procedures to control deviations.
• Review equipment performance and take proactive actions to prevent failures.
• Ensure preventive maintenance, calibration and validation within defined frequencies; plan batches accordingly.
• Ensure raw and packing materials are available in line with business plans.
• Maintain audit-ready downstream facility and documentation at all times.
• Review downstream activities to prevent data integrity issues and simplify where possible.
• Review downstream documents per site procedures and technical requirements.
• Review deviations, change controls, CAPA and other QA/QMS elements.
• Review MFR, BMR, SOPs, Protocols, reports and process documents.
• Ensure EHS policies are followed in the manufacturing area.
• Monitor performance and guide team for smooth day-to-day operations.
• Coordinate with QC, QA, Engineering, Supply Chain, Purchase, Safety, and other stakeholders.
• Collaborate with R&D for development batches and new projects.

Job description

Responsibilities

• To manage day to day activities of downstream operations and activities to be performed as per laid down procedures, which are complying with current cGMP norms.
• Scheduling of the downstream batches
• Reduction of operational cost by evaluating current process requirements, evaluating process, evaluating alternate vendor development
• Analyses of repetitive failure and to provide solution/ develop procedures to bring repetitive deviations under control.
• Review of equipment performance over a period of time and proactively to take action before failure happens.
• Assure that Preventive maintenance, calibration and validation activities are carried out within defined frequency and batches are planned without deviating timelines.
• Ensure the availability of Raw material and Packing material at all times in synchronization with business plans.
• To ensure that downstream facility and documentation is always in a state audit readiness.
• Review of downstream activities which can become potential data integrity issue and laid down procedure / simplify activities for ease to record activities.
• Review of downstream documents record as per technicality and following procedure/ compliance laid down by site.
• Review the deviations, change controls, CAPA and other quality management system.
• Review of MFR, BMR, SOPs, Protocols, reports and other process related documents.
• Assure EHS polices are followed in compliance to current norms in the manufacturing area.
• To monitor performance and guide team member to have smooth flow of working for day-to-day activities.
• Co-ordination with stake holders-QC, QA, Engineering, Supply Chain Management, Purchase, Safety Department etc.
• Work in close coordination with R and D for taking development batches / new projects.