Lowongan Kerja Validation Specialist Esco Bintan Indonesia Batam Terbaru Juni 2025
Lowongan Kerja Validation Specialist Esco Bintan Indonesia Batam Terbaru Juni 2025
Posisi Loker
Validation Specialist
Tanggal
4 September 2024
Perusahaan
Esco Bintan Indonesia
Kota
Batam | No | ID
Tipe Kerja
Full Time
Pendaftaran Validation Specialist Esco Bintan Indonesia. Esco Bintan Indonesia sedang membutuhkan pegawai untuk mengisi posisi sebagai Validation Specialist. Esco Bintan Indonesia menuliskan persyaratan, ketentuan dan spesifikasi pekerjaan sebagai Validation Specialist yang akan ditempatkan di Batam.
Lowongan Kerja Validation Specialist Esco Bintan Indonesia Batam September 2024
Berikut ini adalah deskripsi kerja yang harus penuhi untuk mengajukan lamaran Validation Specialist Esco Bintan Indonesia Batam yang dibuka pada 4 September 2024 ini:
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 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:
S1 (Preferred)
Experience:
Medical Equipment Validation: 1 year (Preferred)
Language:
English (Preferred)
Willingness to travel:
50% (Preferred)
Jika Anda berminat melamar formasi Validation Specialist Esco Bintan Indonesia Batam, segera siapkan persyaratan dan dokumen yang diminta untuk melamar posisi tersebut. Jika Anda memenuhi persyaratan yang dibutuhkan, jangan ragu untuk segera mengirimkan CV Anda. Tunjukkan bakat dan kemampuan Anda, dan dapatkan kesempatan untuk berkarier di perusahaan tersebut. Untuk mengirim lamaran via online, silakan klik tombol "Kirim Lamaran" di bawah ini. Semoga berhasil!
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