Supervisor Clean Line & Clean Room
- PERSOL
- 2 - 5 years
- Hubli
- 5 days ago
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Job Description
The clean line & Clean room Supervisor will oversee and manage the cleaning and passivation process and ensuring the packaging of primary and secondary for medical implants. This role ensures that all cleaning operations and clean room activities are performed according to SOPs, quality standards, and safety guidelines. The supervisor will lead a team of operators, monitor process parameters, maintain equipment, and ensure compliance with regulatory requirements. Essential duties and responsibilities- Responsible for the complete clean line & Clean room activities.
- Operate and supervise cleaning, passivation, and packaging processes.
- Follow the defined SOP and meet the product the quality requirements.
- Monitor and maintain process parameters (temperature, humidity, pressure differentials, air quality) as per ISO Class requirements.
- Verify cleanliness and passivation quality of components before moving to next stage.
- Maintain daily production records, work orders, and non-conformity documentation if any.
- Support for the IQ, OQ and PQ Activities.
- Manage/Handle the required chemical for the process
- Use validated cleaning agents and ensure proper documentation of cleaning logs.
- Ensure proper entry and exit protocols for raw materials, PPE, consumable and finished goods.
- Maintain material segregation and use of pass-through chambers.
- Ensure equipment is cleaned, validated, and calibrated before use.
- Maintain clean line logs, cleaning records, environmental monitoring reports.
- Support audits (internal, external, regulatory) by providing accurate documentation.
- Ensure compliance with ISO 13485 and recommended standards and documentation.
- Train operators and technicians on cleaning process.
- Supervise daily operations and escalate issues to QA or production leads.
- Identify and report any contamination events, equipment failures, or procedural deviations.
- Support CAPA (Corrective and Preventive Actions) and root cause analysis.
- Implement corrective measures and monitor effectiveness
- Ensure material movement and traceability within the shop floor.
- Ability to work in shifts.
- Maintain 5S and workplace discipline & ensure daily preventive maintenance as defined.
- Perform other duties as assigned by the Manager.
- General responsibilities
- Respect and actively contribute to SHE procedures (Safety, Health, Environment).
- Encourage and promote continuous improvement initiatives.
- Interact on time, with transparency & commitment with colleagues & managers
- Maintain respectful and polite relationships with all contacts.
- Uphold and promote the Group's core values.
- Diploma or Any Degree
- 2 5 years of experience in clean line, clean room and passivation or relevant special process operations in medical device.
- Knowledge of ISO13485.
- Preferred background in Medical device implants and related field.
Job Classification
Industry: Recruitment / StaffingFunctional Area / Department: Production, Manufacturing & EngineeringRole Category: Operations, Maintenance & SupportRole: Assembly Line OperatorEmployement Type: Full timeContact Details:
Company: PERSOLLocation(s): Hubli
Keyskills: Supervisor Root cause analysis Usage Shop floor Packaging environment health safety Continuous improvement Room Preventive maintenance Monitoring
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PERSOLKELLY is one of the largest recruitment companies in Asia Pacific providing comprehensive end-to-end workforce solutions to clients. Headquartered in Singapore, the company was established in 2016 and is a joint venture between Kelly Services, Inc. and affiliates of PERSOL HOLDINGS Co. Ltd. To...
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