Officer - Production

RESPONSIBILITIES

• Preparation and review of master batch records / batch manufacturing records, qualification documents (URS, DQ, IQ, OQ, PQ, volumetric calibration, surface area calculation etc.) & QMS documents.
• Preparation and review of standard operating procedure.
• Preparation and review of organogram, job responsibility, training needs & list of list.
• Preparation and review of training matrix & training plan.
• To ensure online documentation related to all CGMP activities including data integrity.
• Initiate, review & complete required change control, deviations, investigations & CAPA impact.
• Reviewing & maintaining all logbooks in the manufacturing area and plant.
• Operation of primary and secondary water treatment plant as per standard operating procedure and look after operations in solvent recovery plant.
• Responsible for performing validation & qualification activities in the plant (equipment qualification, process validation, cleaning validation).
• Responsible for the execution of validation & scale up batches for all the products to be manufactured.
• Proper utilization of available manpower (no contract people) & manufacturing facilities to enhance productivity.
• Ensuring timely manufacturing schedule as per production planning & maintaining quality & safety parameters.

WORK RELATIONS

Interfaces: Internal

• Quality Assurance, Quality Control, EHS, HRA, Warehouse, Engineering

Interfaces: External

• External Vendors.

DESIRED SKILLS

• Must have experience in API production in reputed pharma organizations.
• Should have hands on experience of Manpower Handling
• Strong knowledge of operating DCS (Distributed Control System)
• One Should Manage Shift Planning
• Handling of Water System Operation
• Handling of Process Equipments like Reactor, Centrifuge, RCVD, RVPD, FBD, Bin Blender, Co-mill, etc
• Good Knowledge of preparing BMR and BPR.
• Should have sound knowledge of drafting and reviewing of SOP’s.
• Good Communication and problem solving skills.
• Should be assertive, proactive, and self-driven.
• Ability to work in dynamic environment.