Job Description                        

Followings will be the Coe Job responsibilities of the position holder:

• Compliance to laid standards of current Good Manufacturing Practices (cGMP).
• Carrying, review and approval of qualification of production equipment.
• Ensure compliance with specifications and validated methods.
• Training and evaluation of the Management and Non-Management staff for the qualification to specific task or to operate specific equipment.
• Preparation and review SOPs for related equipment’s and procedures.
• Raising, review of requisition for the requirement of consumables items and check on its inventories according to their approved budget.
• Implementation of Quality Management Systems as per cGMP and international standards.
• Implementation of Corrective and Preventive Actions (CAPA) for non-conformances and self-inspection findings.
• To exercise effective control over environmental conditions in manufacturing and other related activities, which may adversely affect the product quality.
• To Coordinate and approve calibration/maintenance of all production equipment’s and instruments with engineering / QA / QC and outside agencies.
• To carry out routine documentation per regulatory requirements.
• Adhere to specified working hours.
• To ensure and maintain cleanliness of production areas and equipment as per SOPs.
• Coordinate with production, PPIC, QC, CQA, PLM, QA and others for smooth production activities.
• Organize the job responsibilities to the technicians, officers, executives, assistant managers as per plan and to manage absenteeism.
• Verification of dispensed input materials against process orders.
• Continuous monitoring of in-process controls in all production areas. Continuous monitoring and improving production output on daily basis.
• To fill, maintain and approve BPR/BMR online and to ensure online SAP entries.
• To evaluate and sign production records before QA submission.
• To review production and related documentation.
• To Monitor and control of manpower utilization, yield, waste, and Opex.
• To Ensure audit readiness and regulatory compliance.
• Handling of online systems and software and ensure review and approval in systems like SolTRAQs, ISOtrain, Darius, Brainshark, Harmony etc.
• Ensure the compliance of SAP activities related to updation of BOM, creation of new item codes, batch transactions etc.
• Ensure compliance with BBS and BBQ.
• To conduct self-inspection/internal audits as per site Internal Audit Program. To Investigate and provide CAPA for audit observations (internal and external). To conduct cGMP and GDP training in LVP facility.

In absence of the position holder, the sub-ordinate / assistant Manager working in the section, or the authorized designee (as applicable) shall be responsible for day to day working.