Validation Specialist

3 weeks ago

pune, India Quantum Integrators Full time
Role: Mid-Level Validation Tester
Education: Computer Science
Location: Pune/Nagpur
Required Exp: 3 to 5 Year
Shift: EST
We need an ideal candidate who will have a strong background in scientific (Pharma R&D) combined with IT understanding, along with extensive knowledge of GxP and SDLC (cGxP, CFR21 Part 1 1, ISO).
As a Validation Tester, you will be responsible for ensuring that our systems and processes comply with regulatory requirements and industry standards.
Responsibilities :
Managing and Executing Project Deliverables:
Collaborate with project teams to ensure the successful delivery of project goals.
Execute validation protocols and test scripts to verify system functionality.
identifying Process Deviations and Problems:
Identify deviations and potential risks in processes.
Propose solutions to remediate risks and ensure compliance.
3)Conflict Resolution:
Handle conflicts and disagreements within project teams effectively.
4)Root Cause Methodologies and CAPA Implementations:
Apply Root Cause Analysis methodologies to investigate issues.
Implement Corrective and Preventive Actions (CAPA) to address identified problems.
Coaching:
Provide guidance and coaching to project teams on validation processes.
Knowledge and Expertise:
Possess extensive knowledge of Agile/Waterfall framework.
Understand regulatory requirements such as ITIL, GAMP5, Prince2.
Demonstrate excellent verbal and written communication skills.
Exhibit strong compliance writing skills.
7)Audit Support:
Assist in audit preparations and provide support during audits.
8)Global and Local Support:
Offer both local (on-shore/near-shore) and global (off-shore) support as needed.
Requirements :
Bachelor's degree in a relevant field (e.g., Computer Science, Life Sciences).
Certification in ITIL, GAMP5, Prince2 preferred.
Previous experience in audit support and compliance writing.
Proven ability to work with a validation mindset, ensuring compliance throughout processes.
Strong analytical and problem-solving skills.
Detail-oriented with a focus on quality and accuracy.
Ability to communicate effectively with stakeholders at all levels.

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