Key Responsibilities
- Execute calibration and preventive maintenance (PM) activities for analytical instruments and equipment, and review associated records.
- Coordinate with vendors and Facilities & Engineering (F&E) to schedule and complete instrument maintenance and repair activities, including review of service documentation.
- Organize and execute periodic instrument review (PRE) activities and ensure accuracy and completeness of related records.
- Perform or coordinate qualification of analytical instruments, equipment, and computerized systems, including review of qualification documentation.
- Perform or support validation of analytical instrument software, including but not limited to 32Karat, SoloVPE, and EndoScanV.
- Ensure analytical systems are managed and maintained throughout their lifecycle in accordance with established procedures, including: User account management, system configuration control, audit trail review and management
- Support departmentdriven projects and continuous improvement initiatives to enhance productivity and compliance.
- Provide metrologyrelated training to end users and functional teams as required.
- Support development and tracking of timelines for software implementation and validation activities.
- Perform additional duties as assigned by the supervisor.
Additional Responsibilities (Applicable for Lab Administrator Role)
- Support QC computerized system design, qualification, implementation, and routine operation in compliance with GAMP principles, including participation in crosssite alignment or optimization initiatives.
- Ensure computerized systems are maintained in compliance with lifecycle management procedures, including periodic system reviews.
- Assist Validation and IT teams in completing system qualification activities and review documentation
- Perform daily administration of LIMS and other computerized systems, including data configuration, functional enhancements, issue handling, testing, and user training.
- Drive continuous improvement initiatives to enhance efficiency and effectiveness of laboratory computerized systems.
- Administer Empower and other analytical software systems, including project setup, user access management, data storage, backup, restoration, and archiving as required.
- Coordinate with validation teams on design and qualification of Excelbased tools and review related validation documentation.
- Lead or support periodic data integrity reviews of QC analytical systems in accordance with established schedules.
Requirement :
- Diploma or Bachelor's degree in Chemistry, Microbiology, Biochemistry, or a related scientific discipline
- 25 years of experience in a pharmaceutical, biopharmaceutical, or GMPregulated laboratory or manufacturing environment
- Competence in scientific and technical writing for GMP documentation
- Strong analytical thinking, problemsolving, and scientific reasoning skills
- Handson experience in a QC laboratory and GMP environment
- Knowledge of computerized system regulations (e.g. 21 CFR Part 11, EU GMP Annex 11)
- Experience with analytical instrument lifecycle activities (qualification, calibration, PM, troubleshooting) for systems such as UPLC, HPLC, CE, and CIEF
Advantageous Experience
- Analytical instrument operation and sample testing
- Handling deviations, change controls, and audit support
- Use of laboratory and instrument software (e.g. Empower, SoftMax Pro, 32Karat, EndoScanV, LabX, LIMS)
