Job Purpose
To operate, monitor, and maintain pharmaceutical water systems (Purified Water, WFI, Clean Steam, Pretreatment systems) in compliance with cGMP, regulatory, safety, and quality requirements, ensuring continuous availability of quality water for manufacturing, cleaning, and laboratory operations.
Roles & Responsibilities
1. Operation of Water Systems
- Operate and monitor pharma water systems, including:
- Pretreatment systems (DM plant, Softener, RO, EDI, UF)
- Purified Water (PW) generation, storage, and distribution
- Water for Injection (WFI) generation, storage, and loop
- Clean Steam systems (if applicable)
- Ensure systems operate within defined operational and critical parameters (flow, pressure, temperature, conductivity, TOC).
- Ensure uninterrupted supply of compliant water to Production, QC, Warehouse, and Utilities users.
2. cGMP, Compliance & System Control
- Ensure compliance with cGMP, GDP, and regulatory guidelines for water systems.
- Maintain continuous circulation, sanitization, and system integrity as per SOPs.
- Ensure control of microbiological and chemical quality of water.
- Ensure adherence to validated operating ranges for all water systems.
3. Monitoring, Sampling & Trending
- Perform and coordinate online and offline monitoring of water systems.
- Ensure timely sampling of PW, WFI, and feed water as per sampling plans.
- Review and trend conductivity, TOC, microbiology, and system alarms.
- Escalate OOT/OOS trends, deviations, or abnormalities immediately to QA and Engineering Head.
4. Documentation & Data Integrity
- Maintain accurate records of:
- System logbooks
- Operational parameters
- Sanitization records
- Breakdown and corrective actions
- Ensure compliance with ALCOA+ data integrity principles.
- Support preparation and review of SOPs, log sheets, and water system documents.
5. Maintenance & Breakdown Handling
- Carry out preventive maintenance and minor corrective maintenance of utilities equipment.
- Coordinate with maintenance teams and vendors for major breakdowns, repairs, and replacements.
- Ensure availability of critical spares and timely escalation of equipment risks.
6. Sanitization & Validation Support
- Execute and monitor thermal / chemical sanitization of PW and WFI systems.
- Support system qualification and requalification activities (DQ, IQ, OQ, PQ).
- Support cleaning, flushing, and passivation of water systems.
7. Audit & Inspection Support
- Support internal audits, regulatory inspections, and customer audits related to water systems.
- Provide system documents, logs, and explanations during inspections.
- Support CAPA implementation and effectiveness checks for audit observations.
8. Safety, EHS & Housekeeping
- Follow EHS guidelines, MSDS instructions, and lock‑out/tag‑out procedures.
- Ensure safe handling of chemicals used in pretreatment and sanitization.
- Maintain 5S, cleanliness, and safety discipline in utilities areas.
- Report incidents, near misses, or unsafe conditions immediately.