Immediately required Validation Lead at Chicago, IL (Onsite)

Hi,
 
Greetings for the day!!!     
 
This is Rambabu from Tech Orbit Inc. We have an immediate opportunity with one of our clients. Please find the job description below, and if you are interested, please forward your updated resume to rambabu.g@techorbit.com or you can reach me on my number 469-638-7171 for any further information.

 

Requirement details:

 

Title: Validation Lead

Location: Chicago, IL (Onsite)

Duration: Long Term

Experience: 8+ Years

Client: TCS

 

JD:

Prepare timeline, tasks and due date for each validation activities. Collaborate with all stakeholders of different systems to ensure validation timelines are adhered. Support Change Management, System Assessment and Security Assessment of the system Evaluate proposed changes to validated computer systems and recommend level of validation activities required Create/Review/update Validation documents like Validation Plan, System Description document, Requirement specifications, Design Specifications, Configuration specification, Requirement Traceability Matrix, IQ  and OQ protocols, Data Integrity Assessment, Administrative and Operations/Business SOP, Validation Summary Report Work with testing team to develop testing strategy in accordance with client’s policy and procedures Review/Update Test Cases as per Testing procedure Review Test Execution and Defect Management Support User Acceptance Testing Work closely with QA Compliance to ensure appropriate validation of GxP computer systems Provide regulatory guidance on principles of CSV to the expanded team Conduct or facilitate validation and Testing training Ensure Quality & Compliance per Amgen SOPs and Guidelines Highlight risk and propose mitigation plan

Experience Requirements: ·     Minimum 5 years of experience of working as Validation Lead for GxP software development  project. Extensive knowledge on Validation methodologies, processes and regulations, which includes 21 CFR Part 11, Good Automated Manufacturing practice (GAMP 5), Computer Software Assurance (CSA) Experience of working in GMP, GCP and GPvP systems §       Proficiency in authoring and reviewing Validation documents including Standard Operating Procedures, ensuring Good Documentation Practices as per Life Sciences compliance. §      Highly knowledgeable and capable in providing GxP solutions and guiding/mentoring all stakeholders §       Experience of supporting System Assessment/Classification, Risk Assessment and Change Management activities in tools like TrakWise and Service Now. Well versed in ALM and JIRA.

 

Please provide the below details with updated resume, DL and Visa copy.

 

First Name
Last Name
Immigration Status
Current Location
Date of Birth
Phone Number
Email Id
Total IT Exp
Exp in Required Skills
Name of the Degree Highest education
Highest Degree Start Date
Highest Degree End Date
University
Education Type (Full time / Part time)
Passport Number
EX – TCS employee if yes Full time or Contract
Skype ID
LinkedIn ID
References

 

Please share Three interview slots for three consecutive days.

 

Date	From (Time)	To (Time)	Time Zone
09/26/2022
09/27/2022
09/28/2022

 

 

 

 

 

Thanks and Regards,

Rambabu Goud

rambabu.g@techorbit.com

469-638-7171

https://www.linkedin.com/in/rambabu-goud-37b53211b/

1300 W Walnut Hill Ln. #260, Irving, TX 75038.

www.techorbit.com