5-10 years of experience in GxP regulations, especially in the pharmaceutical, biotechnology, or medical device industries.
Expertise in Cloud technologies, GxP applications, and validation processes.
Proven ability to independently manage Business Separation activities for global/regional GxP systems.
Strong skills in Computer System Validation (CSV) during acquisition/divestiture processes.
Proficiency in writing and executing validation documentation such as compliance plans, test protocols, and reports.
Responsibilities
Support GXP applications and cloud concepts with a deep understanding of their infrastructure.
Independently lead Business Separation activities with minimal supervision.
Provide strong oversight in CSV, particularly in separation and acquisition scenarios.
Manage the full lifecycle of validation compliance from inventory assessments to final disposition.
Collaborate with junior and senior resources, offering guidance and expertise in quality processes.
Benefits
Opportunity to work in a fast-paced, regulated environment with direct impact on industry standards.
Gain experience in cutting-edge cloud and SaaS/PaaS technologies essential for modern pharmaceutical operations.
Full Job Description
Roles & Responsibilities:
Need someone strong with GXP applications, saas/paas, infrastructure, quality, cloud concepts, cloud applications, etc.
In addition to validation and regulation experience, the resource should have the following experience:
Must be able to Independently support Business Separation activities for Large global & regional GxP Computerized systems. With minimal supervison.
Strong CSV Expertise, especially within Acquisition/Divestiture/Separation.
bility to manage end-end from Inventory, assessments, remediations to final dispositions;
Infrastructure Qualifications & Business Systems Validations 7-10 years of relevant experience; has experience of leading/advising Junior and Senior resources.
Specifically in the Pharmaceutical, biotechnology, or medical device industry.
Experience:
Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation;
Define and implement Risk based validation activities.
Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports, SOPs/WIs).
Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures.
Skills.
bility to work as a team player, lead a team or accomplish tasks without supervision.
bility to work with remote teams and support several changes/projects simultaneously.
bility to provide Validation guidance, timely reviews, and escalations to management
