Job Description

Essential Duties and Responsibilities:

• Responsible for authorization of Production related documents.
• Maintain the documents as per systems related to cGMP for various statutory and regulatory audits and inspections.
• To actively participate in process validation as well as cleaning validation activity and environmental monitoring as per plan.
• Responsible for the Batch Manufacturing Records review in GMP compliance norms.
• Monitor the Equipment’s breakdown as well as utility maintenance in line with the engineering department.
• Monitor the working of the Assist. Manager and their respective production team. to take corrective action as an when required for the betterment of the production department.
• To guide the safety officer for achieving the desired safety objective in relation to the plant.
  Handling of external audits along with QA department.
• Ensure Safety, Health and hygiene is sustained in the plant by monitoring and taking action on the audit reports.
• Review SOPs as per the QMS guideline.
• Internal Audits of different departments as per internal audit calendar.
• Ensure proper maintenance & housekeeping in the production department.
• Induction training in the new join in the department & on the job training to department staff.
• New product trials and technology transfer adoption as per management guideline.
• Manufacture quality products as per the requirement of the customers and ensure timely delivery for
• the dispatch of the product in close coordination with others department.
• Review and study product parameters, reduce time cycles, improve yields, reduce energy
• conservation, bring down product cost, increase profitability and ensure optimum utilization of the
• plant capacity, Reducing production cost by implementing right first time (RFT)/ failure reduction with
• effective root cause analysis and CAPA implementation.
• Proactive disposal of spent solvent and scrap to reduce hazard inside the premises.
• Focus on Energy Conservation.