*Hi,* * *
*Please take a look at the below requirement details and let me know if you are comfortable with it along with your updated resume* *Validation Manager - 1 position- Salt lake City, UT – Fulltime on Birla soft Payroll- Salary USD 80-90K/Yr * *Requirements: *6-7 years of industry experience within medical device / pharma industry or FDA regulated environment preferred · 2 years of experience in validation management and supervisory roles. · Demonstrated proficiency in application of 21 CFR Parts 11 & 21 CFR Part 820 / 210 / 211 · Basic understanding of § European Regulations (EMEA) § Canadian Regulations (Health Canada) § Japanese Regulations (Ministry of health - MOH) § UK Regulations (MHRA) § Australian Regulations (TGA) · Experience in developing, executing, monitoring, and managing computer system validation activities in GMP regulated industry. · Strong verbal and written communication skills, including presentation and facilitation skills. · Extensive experience negotiating with and influencing internal and external team members · Strong leadership skills with excellent judgment, willingness to make decisions and ability to push back on others (i.e., say no) when appropriate. *Responsibilities:* · Provide guidance and direction to systems owners and technical teams in the development and execution of computer system validation. · Oversees the completion of projects through the development and approval of validation schedules, project plans, master plans, validation protocols and reports for systems that may be complex in nature to support the healthcare industry. · Manages the development, implementation and execution for validation protocols and procedures to ensure computer system validations meet appropriate international regulatory agency validation requirements and internal company standards. · Manages the activities of assigned validation and testing personnel to ensure the quality of completed work. · As required, prepares documentation for regulatory submissions and supports during external or internal regulatory inspections/audits. · Performing risk assessments from a healthcare perspective for computer systems or IT/IS infrastructure (Ex. Networks, Datacenter and Server). · Works closely with other departments to insure compliance is maintained across the enterprise. · System change control compliance management – the review and assessment of system change control documents for regulatory impact and executing the resulting required validation tasks. · Designs, implements, and maintains training programs for validation processes and equipment. * * *Thanks & Regards* *Ahmed* *Software Technology Labs Inc.* *12421 Bob White Lane, Plainfield, IL 60585 Direct: 209 315 8595 | Phone: 406 888 8100 | ** [email protected]* <[email protected]>* **|* *Office Locations: Los Angeles, CA | San Jose, CA | India *The information contained in this e-mail message and any attachments thereto ('e-mail') is intended for the use of only the individual or entity named above. The information may be confidential and protected by, work product immunity or other legal rules. If the reader of this message is not the intended recipient, or an employee or agent responsible to deliver it to the intended recipient, you are notified that retention, dissemination, distribution or copying of this e-mail is strictly prohibited. If you have received this e-mail in error, please immediately notify us by telephone or by e-mail reply, and immediately and permanently delete this e-mail message and any attachments thereto. Thank you. -- You received this message because you are subscribed to the Google Groups "USITJOBS" group. To post to this group, send email to [email protected]. To unsubscribe from this group, send email to [email protected]. For more options, visit this group at http://groups.google.com/group/usitjobs?hl=en. -- You received this message because you are subscribed to the Google Groups "SAP XApps Training/Jobs in Chennai/Bangalore -(0)9444359629" group. To post to this group, send email to [email protected]. To unsubscribe from this group, send email to [email protected]. For more options, visit this group at http://groups.google.com/group/sap-xapps?hl=en.
