Assistant manager

4 weeks ago


Kolhapur, India Unichem Laboratories Limited Full time
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 c GMP 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 c GMP 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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