Validation Specialist

2 days ago

Hyderabad Secunderabad Telangana, India beBeeValidation Full time ₹ 1,04,000 - ₹ 1,30,878
About the Role

We are seeking a skilled Validation Engineer to join our team. In this role, you will be responsible for developing comprehensive test plans and strategies based on project specifications and requirements.

You will perform manual and automated testing of software applications, including functional, regression, and performance testing. Additionally, you will document and report defects identified during testing and collaborate with development teams for resolution.

Your expertise in GxP regulations, specifically 21 CFR Part 11, will be invaluable in defining and performing validation strategies aligned with regulatory requirements. You will also have the opportunity to work with Agile software development methodologies and contribute to the implementation of automation tools and data systems.

Key Responsibilities
  • Develop comprehensive test plans and strategies based on project specifications and requirements.
  • Perform manual and automated testing of software applications, including functional, regression, and performance testing.
  • Document and report defects identified during testing and collaborate with development teams for resolution.
  • Evaluate and adopt tools and technologies to improve automation capabilities.
  • Ensure system compliance with regulatory requirements for data integrity, traceability, and reliability.
Requirements
  • Bachelor s degree and 3 to 5 years of Life Science / Biotechnology / Pharmacology / Information Systems experience or equivalent qualifications and experience.
  • Must Have Skills:
  • Experience in creating and implementing validation protocols (e.g., Installation Qualification (IQ), Operational Qualification (OQ).
  • Solid understanding of GxP regulations, specifically 21 CFR Part 11.
  • Expertise in defining and performing validation strategies aligned with regulatory requirements.
  • Proficiency in automation tools, data systems, and validation software.
  • Experience with Agile software development methodologies (Scrum).
Preferred Qualifications
  • SAFe for Teams certification.
  • Jira, HP ALM experience.
  • Professional certifications in related fields.
What We Offer

We offer a dynamic and collaborative work environment where you can grow and develop your skills. Our team is passionate about delivering high-quality results and making a meaningful impact.

In this role, you will have the opportunity to work on challenging projects, collaborate with experienced professionals, and develop your expertise in validation engineering.

We value diversity, inclusion, and equality and strive to create a workplace that reflects these values. If you are a motivated and talented individual who is passionate about validation engineering, we encourage you to apply for this exciting opportunity.

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