Assistant Manager
1 month ago
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.
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