Assistant Manager / Deputy Manager

Experience

• 10 -15 Years

Qualification

• B. E. Mechanical

Responsibilities

• Execution, validation & scale up batches for all the products to be manufactured at site.
• Operation of equipment in manufacturing & non-manufacturing area as per standard operating procedures.
• Responsible to maintain all critical spares required for utility & manufacturing equipment.
• DCS User ID creation, deletion, locks removal & maintain the record as well as logbooks.
• Identify areas of wastage, area of work simplification and harmonization in documentation practices.
• Examine the environment with a view to minimizing energy consumption.
• Prepare, review, implement and maintain SOPs of engineering department. Train team members and employees on the SOPs.
• Generation & review of history cards, validation protocol, report, layouts, organization charts, written procedure, etc.
• Prepare, review & evaluate QMS activities (Like change controls, deviations, investigations, CAPA, etc)
• Prepare and review documents required for regulatory affairs & its compliance. Compliance of audit observations.
• Ensure report management.
• Ensure compete online documentation related to all cGMP activities including data integrity.
• Ensure getting proper utilities viz. power, compressed air, water, ambient conditions & other related services to various departments as per requirement.
• Co-ordinate with cross functional teams like QA, QC, Production, Material management, EHS, HR for engineering support.
• Proper utilization of available manpower (contract people) & manufacturing facilities for smooth operation of engineering activities.
• Prepare, control, budget for OPEX (material, consumables etc.) & handling CAPEX.

Desired Skills

• Experience in engineering department in a reputable pharmaceutical organization.
• Knowledge of all regulatory compliances and cGMP guidelines.
• Experience of USFDA preferred.
• Good Communication, eye for detail, and problem-solving skills.
• Should be assertive, proactive, and self-driven.
• Ability to work in a dynamic environment.