Offer summary

Qualifications:

10+ years of overall IT experience with 5+ years in Validation Lead roles., Experience with TIBCO (Spotfire, Statistica), OSIPi/OSISoft, and Snowflake for at least 3 years., 4+ years of experience in Life Sciences projects, particularly in Manufacturing/Supply chain/Lab systems., Strong communication and coordination skills, with a proven track record in managing teams and GxP projects..

Key responsabilities:

Lead and manage GxP and non-GxP validation deliverables, including authoring, executing, reviewing, and approving documentation.

Coordinate with internal teams and clients to ensure successful project delivery and communication.

Drive integration testing between data/analytics systems and their integrating platforms.

Implement best practices and guidelines for GxP project execution in the Life Sciences vertical.

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

Job Title

Validation Test Lead

Relevant Experience(in Yrs)

Overall IT Experience: 10 years +

Validation Lead Experience: 5 years +

Test Lead Experience with hands on testing deliverables: 5 years +

TIBCO (Spotfire, Statistica) , OSIPi/OSISoft, Snowflake and other data tools Experience: 3 years+

Life Sciences Projects: 4 years+ with preference in experience working on Manufacturing/Supply chain/Lab systems and data/analytics area

Technical/Functional Skills

Tools sets experience:

Micro Focus ALM (HP ALM)

MS Tools

TIBCO Spotfire, Statistica, Snowflake, OSISoft

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 its 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 team and customers across shores.

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

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

Should have solid experience in creating/executing best practices, guidelines, checklist GxP projects 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

Work as a team, matured communication and coordination skills with client and internal teams/stakeholders. Problem solver.

Required profile