Esco Indonesia menawarkan peralatan berkualitas tinggi, termasuk lemari pengaman biologis, inkubator laboratorium dan oven, inkubator CO₂, lemari asam, lemari aliran laminar, freezer suhu ultra-rendah, isolator farmasi, unit penahanan aliran udara, lemari PCR, sepeda termal, workstation penahanan hewan , Peralatan ART, dan selungkup timbangan penimbangan bubuk. Kami sedang mengembangkan tim kami di Dubai dan kami sangat senang mendengar pendapat Anda.
Pharma Validation ( Pharma Technical Writer)
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 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
Bagi Anda yang berminat, silahakan kirimkan CV Anda ke:
PT. Esco Bintan Indonesia
Jl. Asoka Blok D6-D10 Bintan Industrial Estate, Lobam Kab. Bintan – Prov. Kepulauan Riau
Aplikasi lamaran dikirim via Email ke: [email protected]
INFO LOWONGAN LAINNYA, DAPAT DITEMUKAN DI: T.ME/DISNAKERJA
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