Role: Validation Tester Location: Berkley, CA
Duration: 6 Months • Perform analytical computerized instrument and software validation, spreadsheet validation • and validation periodic review to support a variety of the labs within QC organization. • Prepare IOQ and other life cycle documents with high quality and accuracy. • Write validation protocols and final reports and function as a validation SME. Conduct • computer and software validation, validation periodic review, and Validation Status List • management. • Ensure validations are within compliance by following industry standards, corporate policy, • and regulatory requirement. Interact with Regulatory agencies, customer, and internal • auditors/inspectors as needed. Support regulatory filings with documentation as needed. • Write and/or revise SOPs, and maintain all validation related documentation. • Manage multiple projects with ability to trouble shoot and seek solution. • Frequently acts as an expert and technical resource to laboratory staff and cross functional • areas. • Commitment to safety by following and promoting programs regarding health, safety and • protection of environment. • Coordinate vendors in support of validation projects. • Minimum Education: • Bachelor’s Degree in Science or Engineering *Skills:* • 5-6 years of experience in pharmaceutical or related industry or an equivalent combination · of education and experience. • 2+ years’ experience in performing analytical computerized instrument and software · validation. • Strong understanding of cGMP, 21 CFR Part 11, global regulatory compliance. • Strong technical/business writing and communication skills. • Knowledge in risk assessment, gap analysis, changes control and deviation management. • Strong computer skills, including Word, Excel, PowerPoint and databases. • Strong understanding of Empower. • Must be able to demonstrate knowledge of validation principles, including user · requirements, system specifications, IQ, OQ, and PQ. • Ability and initiative to work with minimal supervision required. • Strong ability to plan and prioritize complex and conflicting objectives to meet release goal. • Excellent organizational skills, capable of multi-tasking and creating validation/qualification · documents for multiple projects simultaneously. • Experience in change control, deviation investigations, and CAPA to ensure compliance. *Thanks and Regards,* *Manu Priya* *Sr. Technical Recruiter* *IDC Technologies* *1851 McCarthy Boulevard, Suite 116|Milpitas, CA , USA, 95035* *408-459-5794 [Direct] I **[email protected]* <[email protected]> *www.idctechnologies.com* <http://www.idctechnologies.com/> *Note: **Due to high volume of calls, I may miss your call, email is the better way to reach me.* -- You received this message because you are subscribed to the Google Groups "SAP Resource Center" group. To unsubscribe from this group and stop receiving emails from it, send an email to [email protected]. To post to this group, send email to [email protected]. Visit this group at https://groups.google.com/group/sap-resource-center. For more options, visit https://groups.google.com/d/optout.
