Lowongan Validation Speacialist di PT Esco Bintan Indonesia

Job Description :

• Collects relevant documents (i.e. Functional and Design Specifications, Draft and Design Drawings) from Design and Project Engineer and counterchecks each with User Requirement Specifications (URS) or As-Ordered Specifications (AOS)
• Provides end-user perspective to engineers to aid in design to satisfy customer requirements
• Attends the Design Qualification (DQ) upon request by the client and communicates with Project Engineer to align client specifications and factory design
• Creates and updates Validation Traceability Matrix (VTM) based on URS or AOS and design reviews
• Authors Factory Acceptance Test (FAT) and Installation Qualification and Operational Qualification (IQ&OQ) protocol
• Coordinates with the team to prepare pre-requisite instruments, certificates, material safety data sheets, test reports, FAT/IQ&OQ schedule, and other necessary documentation prior to FAT/IQ&OQ execution
• Coordinates with purchasing, or contacts the supplier, for documents on their respective products
• Monitors progress of FAT and IQ&OQ
• Performs miscellaneous validation activities
• Drafts ad hoc documents as required by the client for complete documentation
• Analyze equipment designs and develop plans and programs for validation and qualification studies
• Author and implement qualification protocols and standard procedures to execute validation of pharmaceutical equipment
• Execute testing based on protocols
• Employ risk management and validation gap analysis to mitigate and apply remediation measures to existing pharmaceutical process deviations

Competency Requirement :

• Preferably have a degree in Pharmaceutical, Biomedical Engineering, Industrial Pharmacy, or any relevant life sciences course
• At least one (1) year of work experience
• Knowledgeable and/or experience in pharmaceutical validation, equipment validation, quality system implementation, and international pharmaceutical and biopharmaceutical regulations and standards
• Experience in CSV (computerized software validation) dan GMP is a plus
• With commendable technical writing skills, computer literacy, and English language proficiency
• Highly intuitive, analytical, focused, driven, and can work under great pressure
• Willing to work in a multicultural and diverse working environment
• Willing to travel locally and overseas for site acceptance testing and qualification activities