SCHOTT Poonawalla
Website:
schott-poonawalla.com
Job details:
Roles and Responsibilities:
- Ensure smooth operation and preventive maintenance of WFI, Purified Water, PSG, HSRO, and CSRO systems (generation & distribution).
- Monitor system parameters, conduct routine checks, and maintain accurate logbooks.
- Perform troubleshooting, sanitization, and sterilization of pre- and post-treatment water systems.
- Execute daily planning activities related to utility operations and maintenance.
- Liaise with equipment vendors for AMC, servicing, upgrades, and technical support.
- Ensure calibration and maintenance activities are conducted as per SOPs/EOPs.
- Maintain GMP-compliant documentation including logbooks, calibration, and maintenance records.
- Ensure compliance with regulatory requirements such as FDA, EU, and WHO guidelines.
- Handle change controls, deviations, CAPA, and risk assessments related to utility systems.
- Participate in internal and external audits and ensure timely closure of observations.
- Support equipment qualification (IQ/OQ/PQ), requalification, and validation activities.
- Coordinate sampling and testing for microbial and chemical parameters.
- Follow EHS guidelines and ensure safe operations.
- Provide training to junior staff on system handling and GMP documentation practices.
Educational Qualification and Experience:
- BE/B.Tech in Mechanical or Electrical Engineering.
- 3–6 years of experience in the pharmaceutical (sterile) or medical device industry (mandatory).
Competencies and Skills:
- Strong knowledge of utility operations, preventive maintenance, and troubleshooting of water systems (WFI, PW, HSRO, PSG, CSRO).
- Experience in sanitization and sterilization processes for water systems.
- Hands-on experience in audit handling and regulatory compliance.
- Good understanding of GMP, documentation practices, and validation processes.
- Strong analytical and problem-solving skills.
- Good communication and coordination abilities.
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