Manager Production - Sterile Facility

Immacule Life Sciences; Solan; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Immacule Life Sciences in India seeks a QA/QMS leader to ensure strict compliance with the quality management system per cGMP and international standards across production and ancillary areas.

You will implement systems, oversee validation, lead audits, drive process improvements, training, and maintenance planning to optimize yields and safe operations.

Qualifications

• Ensure compliance with cGMP and international regulatory requirements in production.
• Implement systems, processes and procedures to facilitate smooth operations.
• Maintain validated status of the injection facility.
• Ensure SOPs, batch and master documents comply with requirements.
• Coordinate for new product transfers and support validations.
• Coordinate with QA for self-inspection and audit observations.
• Improve product yield and productivity.
• Ensure proper utilization of man and machine and document compliance.
• Plan and review capex and user requirement specifications.

Responsibilities

• Ensure QMS compliance in production and ancillary areas.
• Coordinate with QA for self-inspection and audits.
• Drive improvements in yield and productivity.
• Plan and implement preventive and predictive maintenance schedules.
• Oversee recruitment and performance of subordinates.
• Ensure safety practices are followed.
• Review and approve RM, PM, consumables in ERP.

Skills

Quality management

cGMP compliance

Regulatory compliance

Process improvement

Training management

Equipment maintenance

Capex planning

ERP systems

Tools

ERP system

Job description

Role & responsibilities

• To ensure effective compliance of quality management system as per cGMP and international regulatory requirement in production and ancillary areas.
• Responsible for implementation of systems, processes and procedures to facilitate smooth functioning of overall operations.
• To ensure the execution and maintenance of validated status of the injection facility.
• To ensure effectiveness of all standard operating procedures, batch document, master documents of production and compliance to documents.
• Assuring that the department is in compliance with cGMP/regulatory requirements.
• Co-ordination for new product transfers and thereafter support for process validations.
• Co-ordination with QA for self-inspection and compliance to the audit observations.
• Responsible for improvement in product yield and productivity.
• Proper utilization of man and machine and to ensure compliance for documents as per cGMP requirements.
• To prepare and review capex, user requirement specification etc.
• To prepare and review MIS report and other related documents of production department as per requirements.
• To ensure that initial and continuing training of production persons has been performed as per schedule.
• To confirm the training matrix, training reports of new and existing employees.
• To ensure scheduled validation of the equipment, calibration of devices and maintenance of equipments.
• Responsible for planning and implementation of preventative and predictive maintenance schedules.
• Overseeing the recruitment, performance of subordinates, mentoring/motivating them to improve their contribution levels.
• Responsible for man management and administrative functions and new Project management.
• Responsible for implementation of system, processes and procedures to facilitate smooth functioning of overall operations enhance operational efficiency and cost optimization.
• Market compliant investigation jointly with QA and other CFT’s.
• To comply and ensure the implementation of safety practices.
• To report that entire daily schedules and executions to the management.
• Responsible for self-Inspection as per schedule.
• Review and approval of QMS elements and process documents through ample logic and EDCS system.
• Review and approval of RM, PM, consumable and other dispensing activities through ERP system.

Preferred candidate profile