Computer System Validation Specialist

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 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 Responsibilities
  • Analyzing software application user requirements and performing risk assessments following the CSA approach
  • Developing test cases and scripts according to the risk category of each user requirement
  • Executing test cases and gathering relevant evidence for validation
  • Documenting any deviations or issues identified during testing
  • Preparing CSV lifecycle documentation, as needed
  • Conducting all activities within the Polarion CSV tool in compliance with VMP/Procedures
  • Ensuring compliance with industry regulations, including 21 CFR Part 11, Annex 11, Data Integrity, and data security standards
  • Collaborating with global and India-based teams, ensuring efficient communication and seamless project execution
About You
  • A minimum of 5 years of experience in Computer System Validation (CSV), with a focus on GAMP Category 4 and 5 projects
  • Demonstrated expertise in validating enterprise applications and performing risk-based assessments
  • Strong knowledge of regulatory standards such as 21 CFR Part 11, Annex 11, and Data Integrity guidelines
  • Excellent communication skills with the ability to work independently and within teams
  • Flexibility to work onsite or remotely, depending on project requirements
  • Familiarity with Polarion CSV tool or similar platforms is highly desirable
  • Availability to travel
  • Good knowledge of English
What We Offer

As a member of the PQE Group team, you will have the opportunity to work on international projects, improve your skills, and interact with colleagues from all corners of the world. We offer a challenging and multicultural work environment that values collaboration and innovation.



  • 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...


  • Baddi, Himachal Pradesh, India Instrumentation & Control Solutions Full time

    We are seeking a skilled Computer System Validation Engineer to join our team at Instrumentation & Control Solutions. As a CSV consultant, you will utilize your knowledge of FDA CGMP and related regulations, as well as computer validation methodologies and principles, to perform CSV on various systems and programs.Key responsibilities include:Applying your...


  • 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...


  • 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...


  • 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...


  • 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...


  • 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...


  • Baddi, Himachal Pradesh, India Panacea Biotec Full time

    Job Summary:As a Senior Scientific Officer - Validation, you will play a critical role in ensuring the quality and efficacy of vaccine formulations at our Baddi facility. This position will oversee the qualification/validation of various equipment/systems, including HVAC, filling lines, autoclaves, and utility systems.Key Responsibilities:Oversee the...


  • Baddi, Himachal Pradesh, India Panacea Biotec Full time

    Job SummaryWe are seeking a highly skilled Senior Scientific Officer to join our team at Panacea Biotec. As a Senior Scientific Officer - Validation, you will be responsible for ensuring the quality and efficacy of our vaccine formulations.Key ResponsibilitiesDevelop and execute validation plans to ensure compliance with regulatory requirements and company...


  • Baddi, Himachal Pradesh, India Panacea Biotec Full time

    Job Summary:We are seeking a highly skilled Senior Scientific Officer - Validation to join our team at Panacea Biotec. The successful candidate will be responsible for ensuring the quality and efficacy of our vaccine formulations.Key Responsibilities:Oversee the execution of validation activities, including data collection, analysis, and reporting.Execute...


  • 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...


  • Baddi, Himachal Pradesh, India Colgate-Palmolive Full time

    About Colgate-PalmoliveAt Colgate-Palmolive, we are committed to building a future to smile about. Our dependable household brands, dedicated employees, and sustainability commitments make us passionate about contributing to our employees', consumers', and surrounding communities' enduring success.Job SummaryWe are seeking a skilled Senior Microbiologist...

  • 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...

  • 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...


  • Baddi, Himachal Pradesh, India Acme Generics Full time

    Job Title: Quality Assurance ManagerAcme Generics is seeking a highly skilled Quality Assurance Manager to join our team. The successful candidate will be responsible for ensuring the quality and integrity of our cleaning validation processes.Key Responsibilities:Develop and maintain the Cleaning Validation Master Plan (CVMP) to ensure alignment with...


  • Baddi, Himachal Pradesh, India Acme Generics Full time

    Job Title: Quality Assurance ManagerAcme Generics is seeking a highly organized and detail-oriented Quality Assurance Manager to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the highest standards of quality and compliance in our cleaning validation processes.Key Responsibilities:Cleaning Validation Plan...


  • Baddi, Himachal Pradesh, India Acme Generics Full time

    Job Title: Quality Assurance ManagerAcme Generics is seeking a highly skilled Quality Assurance Manager to join our team. As a key member of our quality assurance department, you will be responsible for ensuring the highest standards of quality and compliance in our cleaning validation processes.Responsibilities:Cleaning Validation Plan Development:Develop...


  • Baddi, Himachal Pradesh, India Acme Generics Full time

    Job Title: Quality Assurance ManagerAcme Generics is seeking a highly skilled Quality Assurance Manager to join our team. As a key member of our quality assurance department, you will be responsible for ensuring the highest standards of quality and compliance in our cleaning validation processes.ResponsibilitiesCleaning Validation Plan Development:Develop...


  • Baddi, Himachal Pradesh, India Seasec Recruiters Full time

    Job SummarySeasec Recruiters is seeking a skilled Application Engineer to join our team. As an Application Engineer, you will be responsible for developing multiple applications, generating clean code, and implementing optimal solutions. This role requires close collaboration with various teams to establish best practices and execute highly functional...


  • Baddi, Himachal Pradesh, India Acme Generics Full time

    Key Responsibilities:Oversee Analytical Quality Assurance activities to ensure compliance with regulatory requirements.Review and approve Quality management system Documents related to Quality control, ensuring accuracy and completeness.Act as the Single point of contact for all submission related activities, including Dossier submission, Regulatory...