Hello , Hope you are doing great! Please find the below mentioned job description and if you are interested revert back with the updated resume to mah...@axiustek.com
Need Only H1, H4 EAD, L2 EAD, GC, USC If H1 Need Passport Number *Position: Validation Engineer with Data Integrity Experience* *Location: Andover, MA* *Duration: Long Term* *Mandatory Skills:* - Proficient in reviewing executed validation documents (change controls, protocols and test plans, validation testing documents, deviations, etc.) - Knowledge of cGMP regulations as they pertain to the pharmaceutical/biopharmaceutical industry. - Thorough understanding of the computer validation lifecycle, including change control - Identify and address any potential quality impact throughout the project *Preferred Skills: * - Bachelor’s Degree in engineering or life sciences - 5 years of computer validation/QA experience in a GMP environment - Experience with change control as a Quality Assurance approver - 1 year of experience with Trackwise change control software (or similar) - Strong experience in working with cross functional teams - Excellent teamwork, flexibility and interpersonal skills *Job Roles/Responsibilities:* The individual will provide Quality Assurance oversight in support of a site project to remediate Data Integrity (DI) commitments. The individual will be responsible for the quality review and approval of validation and change control documentation such as protocols, test plans, various computer validation testing documents, deviations, and change controls in relation to DI remediation activites. The documentation will span the breadth of validation and change control requirements for biopharmaceutical processing therefore validation and quality assurance experience in an manufacturing GMP environment is required. The individual will also ensure that the execution of documents adheres to the governing SOPs, protocols, project plans, cGMP, etc. Upon completion of their review, the individual will also be responsible for the release of equipment back to GMP manufacturing. - Provide QA review of executed validation documents such as change controls, protocols and test plans, validation testing documents, and deviations. - Ensure compliance to governing SOPs, validation plans, and protocols throughout the project. - Release equipment back to GMP manufacturing as part of change control. - Have the ability to independently assess impact and re-testing requirements in the event of a deviation. -- Thanks & Regards Mahesh Gurram Sr. US IT Recruiter Desk No: 703-738-6662 Ext: 2152 Email: mah...@axiustek.com <mah...@sparinfosys.com> *www.axiustek.com* <http://www.axiustek.com/> -- You received this message because you are subscribed to the Google Groups "VB.NET 2003 Group" group. To unsubscribe from this group and stop receiving emails from it, send an email to vbnet2003group+unsubscr...@googlegroups.com. To post to this group, send email to vbnet2003group@googlegroups.com. Visit this group at https://groups.google.com/group/vbnet2003group. To view this discussion on the web visit https://groups.google.com/d/msgid/vbnet2003group/CAJwcDMy%2Bz71Aq8E0THMA3bAiAjtuxTAOcNFoCaO0PsDLBZTgfA%40mail.gmail.com. For more options, visit https://groups.google.com/d/optout.
