OneAPPS Consulting ( is a Technology consulting firm based out of Switzerland and offices across Europe. We are working on various projects involving diverse, multicultural teams with clients across the Europe. We are an invaluable partner and our teams have collaborated to support the growth of our clients. With more than 7 locations worldwide we help our clients to deliver their projects smoothly. We look forward to getting to know you and working with you.
Job Description:
Candidate should have experience to below areas in practical
* Have managed working in the Ops and should have real time experience working on mfg. sites.
* Handling Application Qualification of OT systems at complex or specialty manufacturing
* Fair Understanding on Data Migration Principles
* Fair Understanding on Information Security and SOX Compliance
* Fair Understanding on risk-based methodologies in driving the projects from Quality and Compliance POV
* Information Security and SOX Compliance
* Candidate must have understating on latest regulations i.e. 21CFR Part 11, EU annex 11, and Guidelines e.g. GAMP5 guide.
Candidate will be accountable for:
* Authoring various Qualification and Validation deliverables
* Handling of defects/Deviations
* Investigations
* CAPA Handling
* Test Management & Compliance
Candidate must have fair conceptual understanding on below key areas
* IT QMS
* Validation/Qualification
* Risk management.
* Candidate must be having user friendly experience with Kneat, HP ALM, Kneat and SNOW as tool
* OT System Qualification (Radio ligand Therapy or critical dosage forms will be a plus)
* PAS/DCS Qualification
* ISA95 understanding
* OT Security will be a plus.
* Standalone Systems Qualifications
* PAS/DCS Integrated with Manufacturing Equipment qualification.
Essentials / Desirable
* Professional experience and strong knowledge with real time experience in areas stated above
* IT Quality & Compliance, Computer System Validation / Software Testing / System Implementation in the Life Sciences industry.
* Well versed with Manufacturing, Quality and engineering system and their validations
* Stakeholder management and good executor with required communication.
* Knowledge of Pharmaceutical / Life Sciences as domain.
* Experience to MES, QMS (Trackwise), Lab solutions i.e. LIMS, Empower CDS, Chromeleon, Business Analytics, Middle wares etc. will be an advantage
If this role sounds like you, we invite you to apply. Thanks.
Due to work permit restrictions, we can only consider applications from UK, EU citizens as well as current work-permit holders for Spain.