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 **manu.pr...@idctechnologies.com* <manu.pr...@idctechnologies.com> *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 "Open Source Erp & Crm" group. To unsubscribe from this group and stop receiving emails from it, send an email to open-source-erp-crm+unsubscr...@googlegroups.com. To post to this group, send email to open-source-erp-crm@googlegroups.com. Visit this group at https://groups.google.com/group/open-source-erp-crm. For more options, visit https://groups.google.com/d/optout.
