CSV Consultant - SAP Systems Validations

Job Summary:

Computer System Validation (CSV) Consultant

GxP regulations, 21 CFR Part 11, Annex 11

Key Responsibilities:

• Lead and perform

  CSV activities

  for SAP systems, including validation planning, risk assessments, and test script development (IQ/OQ/PQ).
• Execute validation tasks and compile comprehensive documentation including

  Validation Master Plans (VMP), URS, FDS, RTM, test scripts

  , and

  Validation Summary Reports (VSR)

  .
• Ensure adherence to

  GAMP 5

  ,

  FDA 21 CFR Part 11

  ,

  EU Annex 11

  , and internal quality standards.
• Collaborate with cross-functional teams (IT, QA, Business) to understand system configurations, user requirements, and assess the validation impact of system changes.
• Perform

  impact assessments

  for SAP enhancements, upgrades, patches, and new implementations.
• Support

  periodic reviews

  ,

  change control

  ,

  CAPA

  , and

  audit readiness

  activities for validated SAP environments.
• Provide GxP validation expertise for SAP modules such as

  MM, PP, QM, WM, ATTP, PM

  , and integrated systems such as

  LIMS

  ,

  MES

  , etc.

Required Skills & Qualifications:

• Bachelors or masters degree in

  Life Sciences, Pharmacy, Computer Science

  , or a related discipline.

• 3+ years

  of experience in

  Computer System Validation

  , with a

  minimum of 2+ years in SAP system validation

  .
• Strong hands-on experience with

  SAP ECC

  or

  SAP S/4HANA

  in a GxP-regulated environment.
• Expertise in

  GAMP 5

  ,

  21 CFR Part 11

  , and

  Annex 11

  compliance frameworks.
• Proficiency in developing and reviewing validation documentation across the lifecycle.
• Excellent

  communication skills

  with a proven ability to coordinate across teams and stakeholders.