CPG Regulatory Expert Needed: Nutrition Facts Validation + FDA

plan execute and document computer system validation csv activities in compliance with regulatory requirements gxpfdaema etc develop review validation deliverables including validation plans risk assessments iq oq pq protocols traceability matrices and validation summary reports ...

Infiligence is seeking an experienced Computer System Validation (CSV) Specialist to join their Canadian validation practice in Calgary.This role involves delivering end-to-end computer system validation activities for regulated life science applications. · Lead end-to-end comput ...

Le superviseur validation assure la conformité des activités de validation des procédés dans le respect des exigences réglementaires (GMP, FDA, EMA). · ...

Responsibilities · - Design and deliver AI governance operating models, validation frameworks, and oversight structures tailored to biopharma and CRO environments · - Lead data readiness and risk assessments for clients evaluating or deploying AI systems in clinical and commercia ...

We are developing a sophisticated medical device that integrates Mechanical Design, Electrical Hardware, Firmware and AI Models. We are looking for a Quality/Regulatory specialist to audit our current project structure on OneDrive and reorganize it into a compliant Design History ...

We are developing an FDA Regulatory Co-Pilot for medical device classification and regulatory pathway support (510(k), De Novo). We are looking for an experienced FDA regulatory specialist to perform a short structured test of the system. · Spend approximately 1–2 hours testing t ...

The Process Engineer (Product Development) supports the design development validation and transfer of manufacturing processes for medical devices.This role ensures robust compliant processes aligned with ISO 13485 FDA 21 CFR 820 and customer requirements supporting successful pro ...

FDA 510(k) Consultant Needed for Medical Device Submission · Description: · We are seeking an experienced **FDA regulatory consultant** to assist with preparing and filing a **510(k) submission** for our medical device. The ideal candidate will have a strong background in **FDA r ...

ValGenesis is a leading digital validation platform provider for life sciences companies. ValGenesis suite of products are used by 30 of the top 50 global pharmaceutical and biotech companies to achieve digital transformation, total compliance and manufacturing excellence/intelli ...

ValGenesis is a leading digital validation platform provider for life sciences companies. ValGenesis suite of products are used by 30 of the top 50 global pharmaceutical and biotech companies to achieve digital transformation, total compliance and manufacturing excellence/intelli ...

I need someone to support a client in EU AND US who are implementing a validation program. · ...

We are seeking an experienced Pharmacovigilance Safety Systems E2B (R2/R3) Specialist to lead electronic safety reporting activities in a regulated environment. · ...

FOP CONSULTANTS est à la recherche de consultants en validation des systèmes et équipements motivés à la réalisation de mandats. · Rédiger, superviser et/ou exécuter les protocoles IQ, OQ et PQ des équipements et systèmes. · Participer à la mise à jour du PMV. · Document any disc ...

Nous recrutons un(e) Directeur(trice), Sciences et technologies de la fabrication. · Définit et met en œuvre les stratégies de développement et de transfert technologique pour les produits pharmaceutiques. · Gère et suit le budget, incluant les contrats de sous-traitance. · Assur ...

We are seeking an experienced Computer System Validation (CSV) Specialist to review, assess, and enhance our draft CSV Standard Operating Procedures (SOPs) and associated forms/templates. · Evaluate existing materials · Identify gaps · Update content directly within the documents ...

We re looking for an experienced eCTD Submission Specialist who has experience supporting compiling publishing and validating regulatory submissions in eCTD format for global health authorities. · Compile and publish submissions in eCTD format Modules 1–5 for EMA FDA and/or Healt ...

This engagement is being conducted on a personal capacity basis. We are seeking an experienced Computer System Validation (CSV) Subject Matter Expert (SME) to provide advisory support during the development of CSV SOPs and policies for a regulated life sciences environment. Docum ...

Nous recrutons un(e) Directeur(trice),Sciences et technologiesde lafabrication. · RÉERcollectifRégimedassurancecollective dèsledjour1(primepayéeà100%parlemployeur)TélémédecineProgrammed'aideauxemployés(PAE)Santètbien-êtreActivitésduclubsocial ...

Rejoignez un leader mondial où précision, mission et innovation s'unissent. · Soutien à la qualité et à la conformité · ...

The Engineer in Design Control strategically plans and executes design control activities in collaboration with project core teams and functional stakeholders. · Expert in design control and risk management processes including FDA 21 CFR. · Understand, interpret and educate proje ...