Offer summary

Qualifications:

Experience in GMP Data Validation and core experience in TIBCO tools (Spotfire, Statistica) and Snowflake., Solid integration testing experience between data/analytics systems and integrating systems., Proven validation lead experience in pharmaceutical companies with client-facing roles., Strong communication and coordination skills, with a track record of managing teams for successful project delivery..

Key responsabilities:

Manage and drive GxP and non-GxP deliverables as a hands-on Validation/Test lead.

Author, execute, review, and approve validation deliverables.

Coordinate with internal teams and clients to ensure project success.

Implement best practices and guidelines for GxP project execution.

RxCloud is a professional services organization focused exclusively on Pharma, Biotech and Medical device industries. We are a full-scale Quality Assurance Organization driving innovation & ensuring compliance across the industry. Our mission is to deliver Quality, Compliance, Innovation, Customer Experience, and speed that enables global Life Science industry to continuously innovate and significantly reduce drug development life cycle. We are specialized in providing the CSV services, GxP Audits (GMP, GDP, GLP, GCP, GVP) as a service, Veeva Services, Software Quality Assurance services. Our full spectrum of service offerings includes QMS Consulting, End to End Global Audit Management, CAPA management, SOP Authoring, QA as a service. RxCloud’s differentiation is bringing in speed and agility to achieve compliance first time and every time.

Job description

Technical/Functional Skills

Tools set experience:

Micro Focus ALM (HP ALM)
MS Tools
TIBCO Spotfire, Statistica, Snowflake, OSI Soft

Experience Required

Dynamic individual with lots of GMP Data Validation experience with core experience in TIBCO (Spotfire, Statistica), OSIPi, Snowflake, and other data tools.

Need solid integration testing experience between the data/analytics system/platform and it's integrating systems.

Should have solid validation lead experience working for pharmaceutical companies as Val lead, in direct client-facing roles.

Should have great communication and coordination skills (proactive and driving) between internal teams and customers across shores.

Should have a good track record in managing teams to successful project delivery.

Should have a good understanding and experience in execution and managing GxP projects and deliverables.

Should have solid experience in creating/executing best practices, guidelines, and checklist GxP project execution. Worked in Life Sciences vertical both GxP and non-GxP space.

Familiar with Life science business process flow.

Roles & Responsibilities

Hands-on Validation/Test lead who manages and drives GxP and non-GxP deliverables who can author, execute, review, and approve deliverables
Generic Managerial Skills