27 oct
|
Planet Pharma
|
Comunidad Valenciana
27 oct
Planet Pharma
Comunidad Valenciana
We are partnering with a global Life Sciences organisation undergoing a number of critical digital and compliance initiatives and are seeking an experienced Validation Manager to lead validation activities across regulated clinical and quality systems. This is an excellent opportunity for a hands‑on CSV professional who combines strong validation expertise with leadership capabilities and experience operating within highly regulated GxP environments.
Key Responsibilities
* Lead validation activities for regulated GxP systems throughout the SDLC.
* Author and review validation deliverables including URS, risk assessments, test scripts, test execution evidence, validation reports and traceability documentation.
* Collaborate with business, quality, IT and vendor stakeholders to ensure compliant system implementation and operation.
* Provide guidance on Computer Systems Validation (CSV), data integrity and regulatory compliance requirements.
* Support validation activities across clinical, quality and enterprise platforms.
5+ years' experience in Computer Systems Validation within Life Sciences Strong validation experience across clinical and quality systems, including:
* Clinical Systems (CTMS, EDC, IRT advantageous) Experience validating or implementing Learning Management Systems (LMS), ideally:
* SumTotal
* Cornerstone
* SuccessFactors LMS
* Similar regulated LMS platforms Experience with Identity & Access Management systems, including:
* OKTA
* Identity Service Cloud
* SSO / Access Management platforms Strong understanding of:
* GAMP 5
* Annex 11
* 21 CFR Part 11
* Data Integrity principles Hands‑on experience creating and reviewing:
* URS
* Functional Requirements
* Test Scripts
* Validation Documentation
* Test Reports Previous leadership, team lead or line management experience
* Business Analysis skills
* Process mapping and data flow analysis
* General pharmaceutical, biotechnology or CRO environments #J-18808-Ljbffr
📌 Validation Manager (Comunidad Valenciana)
🏢 Planet Pharma
📍 Comunidad Valenciana