20 Aug
|
AZENTYX HEALTHCARE
|
Baddi
20 Aug
AZENTYX HEALTHCARE
Baddi
JOB DESCRIPTIONWater System Operator – Pharmaceutical Industry
Department: Engineering / Utility
Designation: Water System Operator
Reporting To: Engineering / Utility Head
Location: Pharmaceutical Manufacturing Plant
Employment Type: Full-Time
1. Job Purpose
To operate, monitor, maintain, and document the pharmaceutical water generation and distribution systems in accordance with GMP, SOPs, safety requirements, and company procedures, ensuring continuous availability of quality water for manufacturing operations.
1. Key Responsibilities
- Operate and monitor Purified Water (PW), Water for Injection (WFI), RO, DM/EDI and water distribution systems, as applicable.
- Monitor system parameters such as pressure, flow, temperature, conductivity, TOC and other specified parameters.
- Operate RO, UV, EDI, ozone, filtration, softener and related utility equipment as per approved SOPs.
- Conduct routine start-up, shutdown, flushing and sanitization activities as per approved procedures.
- Ensure proper operation of water storage tanks, pumps, pipelines, valves and distribution loops.
- Record daily operating parameters and readings in logbooks/BMR/electronic systems, as applicable.
- Maintain accurate and contemporaneous documentation as per Good Documentation Practices (GDP).
- Perform routine checks of water-system equipment and immediately report abnormalities, alarms, leaks or breakdowns.
- Coordinate with the Engineering, Production and Quality Assurance/QC departments for water-system activities.
- Assist in preventive maintenance, breakdown maintenance, calibration and qualification activities.
- Ensure proper execution of system sanitization and cleaning activities.
- Support sampling activities as per approved SOPs and coordinate with QC for water testing.
- Maintain the required temperature, pressure, flow and quality parameters within specified limits.
- Report any out-of-specification (OOS), out-of-trend (OOT), deviation or abnormal observation to the concerned department immediately.
- Follow all approved SOPs, GMP, EHS and safety procedures.
- Ensure the water system area remains clean, organized and compliant with GMP requirements.
- Participate in internal audits, regulatory inspections and customer audits whenever required.
- Ensure proper handover of system status and pending activities to the next shift.
- Perform any other utility-related responsibilities assigned by the Engineering/Utility Head.
1. Equipment / Systems Handled
- Reverse Osmosis (RO) System
- Purified Water (PW) System
- Water for Injection (WFI) System, where applicable
- DM/EDI System
- UV System
- Ozone Generation System
- Filtration Systems
- Water Storage Tanks
- Distribution Loops
- Transfer & Circulation Pumps
- Heat Exchangers
- Softener / Multimedia Filter
- Online Monitoring Instruments
1. GMP & Documentation Responsibilities
- Follow applicable WHO-GMP / Schedule M / EU-GMP requirements, as applicable to the facility.
- Follow approved SOPs and work instructions.
- Maintain complete and accurate equipment/system logbooks.
- Follow ALCOA+ principles for documentation.
- Ensure no unauthorized changes are made to system parameters.
- Immediately report deviations and abnormal conditions.
- Maintain proper records of sanitization, cleaning, maintenance and operational activities.
1. Safety Responsibilities
- Follow all plant EHS and safety procedures.
- Use required PPE while operating and maintaining the system.
- Handle chemicals used for water-system cleaning/sanitization safely.
- Follow electrical and mechanical safety procedures.
- Report unsafe conditions, leaks, spills and equipment hazards immediately.
1. Qualification
Minimum: ITI / Diploma in Mechanical, Electrical, Chemical or related technical discipline. Preferred: Diploma/ITI with experience in pharmaceutical utility/water systems.
1. Experience
Preferred: 1–5 years of experience in pharmaceutical manufacturing, particularly in Purified Water/RO/DM/EDI/WFI and utility systems. Pay: ₹15,086.00 - ₹25,970.25 per month
Advantages
- Food provided
- Leave encashment
- Life insurance
- Paid sick time
- Paid time off
- Provident Fund
Work Location: In person
📌 Water System Operator (Baddi)
🏢 AZENTYX HEALTHCARE
📍 Baddi