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
2-5 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)

Lab Analyst, QC (Metrology)