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
Preferably have a degree in Biology, Pharmacy, Biomedical Engineering or any relevant life sciences course- At least one (1) year of work experience. Fresh graduates are welcome to apply.
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
Job Type: Full-time
Ability to commute/relocate:
- Batam: Reliably commute or planning to relocate before starting work (Preferred)
Education:
Experience:
- Medical Equipment Validation: 1 year (Preferred)
Language:
Willingness to travel:
* 50% (Preferred)
