GxP Validation Manager - QA Testing
- Genpact India
- 5 Yrs
- Bengaluru
- 4 years ago
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Job Description
*GxP Validation Manager, QA-Testing
Function: Operations
Bangalore
With a startup spirit and 90,000+ curious and courageous minds, we have the expertise to go deep with the world s biggest brands and we have fun doing it. Now, we re calling all you rule-breakers and risk-takers who see the world differently, and are bold enough to reinvent it. Come, transform with us.
Inviting applications for the role of GxP Validation Manager, QA-Testing
When building software, we will be going through many stages from initial requirements to go live, it s important to ensure that everything works according to specification.
That s why we re looking for a quality assurance engineer to help us maintain our high level of quality.
QA tester will hunt bugs, identify issues, report them, and see that they re dealt with
Are you the one we are looking for
Responsibilities:
- To manage all validation (CSV- Computer System Validation) activities of category 3/4/5 tools (COTS/Configurable/Custom tools)
- To work with QA and assess the GxP applicability of the tools
- To write Computer System validation and test protocols/plans
- To review and approve User/System/Design requirements
- To review and approve traceability of requirements against test results
- To review and approve test case documents
- To review work instructions of the system
- To review the validation results and close the defects.
- To draft the summary reports
- To provide the assessments to change requests
- To work closely with all departments and the Quality Department to ensure the operation of a validated environment according to GMP and other regulatory requirements
- To Manage all facets of assigned validation projects while maintaining strong communication with client representative on project status and assistance needed.
- Scheduling, Planning and review of validation activities.
Qualifications we seek in you
Minimum qualifications:
B.tech in any relevant branch
Preferred qualifications:
- Any degree in a science/engineering/computer subject as a minimum.
- At least 5 years experience of Validation Management experience ideally within the healthcare/pharmaceutical domain.
- Good understanding and application of GMP and regulatory requirements.
- Good understanding of GAMP guidelines and QMS system and adopt to the current validation system
- Experience in FDA 21 CFR Part 11 and Part 820
- Experience in IQ/OQPQ protocol drafting
- Experience in validation life cycle for all kind of tools (COTS/Configurable/Custom)
- Good exposure in CAPA/HIPAA/NC
- Experience of wide range of validations including Computer Systems Validation and validation plans/reports.
- Excellent communication / interpersonal skills
Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, physical or mental disability or any other characteristic protected by applicable laws. Genpact is committed to creating a dynamic work environment that values diversity and inclusion, respect and integrity, customer focus, and innovation. For more information, visit www.genpact.com. Follow us on Twitter, Facebook, LinkedIn, and YouTube.
,Employement Category:
Employement Type: Full timeIndustry: IT - SoftwareRole Category: General / Other SoftwareFunctional Area: Not ApplicableRole/Responsibilies: GxP Validation Manager - QA TestingContact Details:
Company: Genpact IndiaLocation(s): Bengaluru
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