Manager Production

LVP Production Job Description

Followings will be the core Job Responsibilities of the position holder:

• Compliance to laid standards of the current good manufacturing practices.
• Carrying, review and approval of Qualification of Production equipment.
• Compliance to specifications and validated methods.

Training and evaluation of the Management and Non-Management persons for their qualification to specific task or to operate specific equipment. Preparation, review and approval of Standard Operating Procedures, for related equipments and procedures. Raising, review of requisition for the requirements of consumables items and check on its inventories according to their approved budget. Implementation of Quality Management System as per cGMP and international requirement at all levels of Manufacturing. Corrective and Preventive actions implementation for observed non-conformance & self inspection points. To exercise effective control over the environmental conditions in Manufacturing and other

related activities, which may adversely affect the product quality.

To co-ordinate and approve the calibration / preventive maintenance for all production equipments and instruments with engineering / QA / QC & outside agencies. To carry out routine documentation as per Regulatory Requirements.

To work within the specified working hours.

To ensure maintenance of production area and equipments in the state of cleanliness as per the SOPs at all points of time. Coordination with PPIC, QC, CQA, PLM, QA and other cross functional departments for smooth production activities. Organizing the job responsibilities to the technicians, officers, executives, assistant managers as per plan & control on absenteeism. Verification of input materials against plan and its checking as per process work orders

• To ensure continuous process improvisation in all production areas.
• Continuous monitoring and improving the production output on daily basis.
• To fill and maintain and approve the BPR/ BMR online and to ensure online entries in SAP.
• To evaluate and sign the production records before they are sent to the QA department.
• To maintain /fill and review the formats of Production and other related documents.
• Monitoring and Control of manpower utilization, yield, waste data and Opex.
• To ensure compliance w.r.t. regulatory agencies and ensure all-time audit readiness.

Handling of online systems and software and ensure review and approval in systems such as SolTRAQs, ISOtrain, Darius, Brainshark, Harmony etc. Ensure the compliance of SAP activities related to updation of BOM, creation of new items

codes, batch transactions etc. for smooth production activities.

• To ensure the compliance BBS and BBQ in the area.
• To conduct the Self-inspection/ internal audit as per site Internal Audit Program.
• To investigate and provide CAPA for self-inspection/ internal audit and external audit observation. To conduct cGMP and GDP training of employees in LVP facility.