Senior CSV Expert

3 weeks ago

Baddi, Himachal Pradesh, India PQE Group Full time

About the Role:

We are seeking a highly skilled Senior CSV Expert to join our team at PQE Group. As a Senior CSV Expert, you will be responsible for analyzing software application user requirements and performing risk assessments following the CSA approach.

Key Responsibilities:

  • Analyze software application user requirements and perform risk assessments following the CSA approach
  • Develop test cases and scripts according to the risk category of each user requirement
  • Execute test cases and gather relevant evidence for validation
  • Document any deviations or issues identified during testing
  • Prepare CSV lifecycle documentation, as needed
  • Conduct all activities within the Polarion CSV tool in compliance with VMP/Procedures
  • Ensure compliance with industry regulations, including 21 CFR Part 11, Annex 11, Data Integrity, and data security standards
  • Collaborate with global and India-based teams, ensuring efficient communication and seamless project execution

About You:

To be successful in this role, you will need to have a minimum of 5 years of experience in Computer System Validation (CSV), with a focus on GAMP Category 4 and 5 projects. You will also need to have demonstrated expertise in validating enterprise applications and performing risk-based assessments.

What We Offer:

As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. We offer a rewarding and exciting career, with opportunities to work on international projects, improve your skills, and interact with colleagues from all corners of the world.

  • Senior CSV Expert

    3 weeks ago

    Baddi, Himachal Pradesh, India PQE Group Full time

    About the RoleWe are seeking a highly skilled Senior CSV Expert to join our team at PQE Group. As a key member of our team, you will be responsible for ensuring the validation of our computer systems meets the highest standards of regulatory compliance.Key ResponsibilitiesAnalyzing software application user requirements and performing risk assessments using...

  • Computer System Validation Specialist

    3 weeks ago

    Baddi, Himachal Pradesh, India PQE Group Full time

    About the RoleWe are seeking a highly skilled and experienced Computer System Validation (CSV) expert to join our team at PQE Group. As a Senior CSV Expert, you will be responsible for supporting our projects in Baddi, Himachal Pradesh, and collaborating with our global and India-based teams.Key ResponsibilitiesAnalyze software application user requirements...

  • Computer System Validation Specialist

    3 weeks ago

    Baddi, Himachal Pradesh, India PQE Group Full time

    About the RoleWe are seeking a highly skilled Senior CSV Expert to join our team in Baddi, Himachal Pradesh. As a key member of our global team, you will be responsible for supporting our projects and collaborating with our India-based team.Key ResponsibilitiesAnalyzing software application user requirements and performing risk assessments following the CSA...

  • Computer System Validation Engineer

    3 weeks ago

    Baddi, Himachal Pradesh, India PQE Group Full time

    About the RolePQE Group is seeking a highly skilled and experienced Computer System Validation Engineer to join our team in Baddi, Himachal Pradesh. As a Senior CSV Expert, you will be responsible for validating enterprise applications and performing risk-based assessments.Key ResponsibilitiesAnalyzing software application user requirements and performing...

  • Computer System Validation Engineer

    3 weeks ago

    Baddi, Himachal Pradesh, India PQE Group Full time

    About the RoleWe are seeking a highly skilled Senior CSV Expert to join our team at PQE Group. As a key member of our team, you will be responsible for ensuring the compliance of our computer systems with regulatory standards.Key ResponsibilitiesAnalyzing software application user requirements and performing risk assessments following the CSA...

  • Computer System Validation Specialist

    3 weeks ago

    Baddi, Himachal Pradesh, India PQE Group Full time

    About PQE GroupPQE Group is a world leader in the Pharmaceutical and Medical Device industries, with 40 subsidiaries and over 2000 employees in Europe, Asia, and the Americas. We are seeking a Senior CSV Expert to support our projects in Baddi, Himachal Pradesh.Key ResponsibilitiesPerform risk assessments and develop test cases for software application user...

  • Computer System Validation Specialist

    3 weeks ago

    Baddi, Himachal Pradesh, India PQE Group Full time

    About the RoleWe are seeking a highly skilled Computer System Validation Specialist to join our team at PQE Group. As a Senior CSV Expert, you will play a critical role in supporting our projects in Baddi, Himachal Pradesh.Key ResponsibilitiesAnalyse software application user requirements and perform risk assessments following the CSA approach.Develop test...

  • Computer System Validation Engineer

    3 weeks ago

    Baddi, Himachal Pradesh, India PQE Group Full time

    About the RoleWe are seeking a highly skilled Senior CSV Expert to join our team at PQE Group. As a key member of our team, you will be responsible for ensuring the validation of our computer systems meets the highest standards of regulatory compliance.Key ResponsibilitiesAnalyzing software application user requirements and performing risk assessments...

  • Senior Scientific Officer

    3 weeks ago

    Baddi, Himachal Pradesh, India Panacea Biotec Full time

    Job Summary:As a Senior Scientific Officer - Validation, you will play a crucial role in ensuring the quality and efficacy of vaccine formulations at Panacea Biotec. This position involves overseeing the qualification/validation of various equipment/systems, including HVAC, filling lines, autoclaves, and utility systems.Key Responsibilities:Develop and...

  • Senior Software Engineer

    1 week ago

    Baddi, Himachal Pradesh, India Colgate-Palmolive Full time

    Key Responsibilities:Design and develop cutting-edge AI and machine learning modelsCollaborate with cross-functional teams to integrate AI solutions into existing systemsStay up-to-date with the latest advancements in AI and machine learningRequirements:Proven experience in AI and machine learning developmentFamiliarity with data science tools and...

  • Computer System Validation Engineer

    3 weeks ago

    baddi, India PQE Group Full time

    Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas.Due to our constant growth, we are looking for a Senior CSV Expert to support our...

  • Computer System Validation Engineer

    3 weeks ago

    Baddi, India PQE Group Full time

    Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries ? PQE Group has been at the forefront of these industries since 1998 , with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas . Due to our constant growth, we are looking for a Senior CSV Expert to...

  • Computer system validation engineer

    3 weeks ago

    Baddi, India PQE Group Full time

    Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries ? PQE Group has been at the forefront of these industries since 1998 , with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas . Due to our constant growth, we are looking for a Senior CSV Expert ...

  • Computer System Validation Engineer

    2 months ago

    Baddi, India PQE Group Full time

    Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas.Due to our constant growth, we are looking for a Senior CSV Expert to support our...

  • Computer System Validation Engineer

    2 months ago

    baddi, India PQE Group Full time

    Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas.Due to our constant growth, we are looking for a Senior CSV Expert to support our...

  • Computer System Validation Engineer

    2 months ago

    baddi, India PQE Group Full time

    Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries ? PQE Group has been at the forefront of these industries since 1998 , with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas . Due to our constant growth, we are looking for a Senior CSV Expert to...

  • Computer System Validation Engineer

    1 month ago

    Baddi, India PQE Group Full time

    Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas.Due to our constant growth, we are looking for a Senior CSV Expert to support our...

  • Computer System Validation Engineer

    2 months ago

    Baddi, India PQE Group Full time

    Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries ? PQE Group has been at the forefront of these industries since 1998 , with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas . Due to our constant growth, we are looking for a Senior CSV Expert to...

  • Computer System Validation Engineer

    1 month ago

    baddi, India PQE Group Full time

    Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas.Due to our constant growth, we are looking for a Senior CSV Expert to support our...