REQUIREMENTS

•          Preferably have a degree in Pharmaceutical, Biomedical Engineering, Industrial Pharmacy, or any relevant life sciences course
•          At least one (1) year work experience
•          Knowledgeable and/or experienced in pharmaceutical validation, equipment validation, quality system implementation, and international pharmaceutical and bio – pharmaceutical regulations and standards
•          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 multi-cultural and diverse working environment
• Willing to travel locally and overseas for site acceptance testing and qualification activities

RESPONSIBILITIES

Placement: Bintan, Indonesia

• 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