What are the responsibilities and job description for the Computer System Validation Lead position at iTvorks,Inc?
Company Description
iTvorks provides answers to enterprises in a wide range of business sectors such as medical, real estate, and finance among others. We have reliably helped many organizations see their visions come to life by entirely managing the lifecycles of their products, infrastructure and applications.
Job Description
Candidate needs to work from our Client site Based in Foster City CA.
- 21 CFR Part 210 / 211
- GAMP 5 Risk-Based validation / ICH Q9 hands-on implementation knowledge
- Manufacturing, Distribution process and procedure
- Experience in managing large implementations/upgrade project
- Strong knowledge on change management procedure & process; Should have handled more than 20 change requests
- Hands-on knowledge of Deviation and CAPA Management
- Leading and managing testing and validation activities in synchronization with project scope, schedule, and objective
- Must possess formal training/certification on Testing & Validation
- Excellent communication skills
- Excellent technical writing skills
- Should be able to work independently with minimum supervision
Should have worked in cross-functional environments and comfortable to liaison with business
Qualifications
Below applications Experience Must.
- SAP
- Oracle EBS
- LIMS
- VEEVA or Salesforce
Additional Information
All your information will be kept confidential according to EEO guidelines.