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Job details

  • aneta sekovanikSkopje
  • Salary po dogovor
  • Employment typePermanent
  • Number of working places1
  • Contact phoneJob appication is expired
  • Contact emailJob appication is expired
  • Websitehttps://panaxia.co.il/
  • Job codeTHGHFLH

(INACTIVE) - ELEKTRO / MASHINSKI INZINER

Job details

Job Description: Systems and Qualification Engineer for a small-scale pharmaceutical company located in Malta

Position Overview:

The Systems and Qualification Engineer is responsible for ensuring that equipment, facilities, utilities, and automation systems within the pharmaceutical company are suitable for their intended use. This role involves developing and executing qualification documentation to support the System Life Cycle, adhering to government regulations (EU-GMP) and company policies.

Key Responsibilities:

Qualification Documentation: Develop User Requirement Specifications (URS), Verification Plans, Commissioning protocols (FAT/SAT, Hardware & Software Tests), Area Qualification protocols (ISO 7 & 8), Installation/Operation Qualification protocols, and Performance Qualification protocols. Prepare specifications for purchasing materials or equipment. Execute commissioning and qualification protocols for GMP Areas, Utilities, manufacturing, and packaging equipment. Qualify instrumentation (IQOQPQ) and automation/computerized systems. Equipment Maintenance: Develop and implement preventive maintenance and calibration schedules for critical equipment. Execute timely calibration, servicing, and repairs. Troubleshoot equipment issues and collaborate with vendors for technical support. Maintain accurate records of maintenance activities, including calibration certificates and service reports. Misc.: Decommission facility, utility, and equipment (including computerized systems). Coordinate with QA, QC and manufacturing departments.

Qualifications:

Bachelor’s degree (at least) in Engineering or related field. Knowledge of relevant EU-GMP regulations and industry best practices. Strong technical and analytical skills and attention to detail. Excellent communication and collaboration abilities. An experience of at least 2 years as a Systems and Qualification Engineer in a pharmaceutical company.

 

 

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