Offer summary

Qualifications:

At least 10 years of experience in computer systems validation activities., Minimum of 7 years in GMP/GxP regulated environments., Proven ability to develop full validation documentation and testing protocols., Familiarity with FDA 21 CFR Part 11 and validation of enterprise systems like SAP or MES..

Key responsabilities:

Lead the development of scalable validation strategies and documents.

Perform document reviews to ensure compliance with validation standards.

Oversee the validation of life sciences systems and ensure continuous compliance.

Utilize test management tools to support validation processes.

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

At least 10 years of experience supporting and/or performing all aspects of computer systems validation activities including development of scalable validation strategies, documents, and perform document reviews
At least 7 years prior experience in computer systems validation within GMP/GxP regulated environments
Proven experience developing full validation documentation and testing protocols within the various SDLC phases that is scalable and maintainable to demonstrate continuous compliance
Experience with FDA 21 CFR Part 11
Experience with the validation of Enterprise systems SAP and/or MES system Preferred. Validation of Life sciences systems such as Veeva, Trackwise, Argus, Clnical, Quality systems highly desired.
Broad understanding of the test management Tools, including experience and knowledge Microfocus ALM, ValGenesys etc preferred.
Knowledge and experience around CSA highly preferred.

Required profile