The role involves assisting in the planning, execution, and documentation of Computer System Validation activities including risk assessments and qualification protocols
Job Summary
The role involves assisting in the planning, execution, and documentation of Computer System Validation activities including risk assessments and qualification protocols.
Candidates will collaborate with cross-functional teams such as Quality Assurance, IT, and Manufacturing to ensure systems meet compliance standards.
PwC offers a vibrant community focused on trust, innovation, and inclusive benefits that support personal growth and wellbeing.
Matching Summary
The role involves assisting in the planning, execution, and documentation of Computer System Validation activities including risk assessments and qualification protocols.
Skills & Requirements
Must-have
Computer System Validation (CSV)
Instrument Qualification IQ OQ PQ
Regulatory compliance GxP FDA 21 CFR Part 11
Validation lifecycle documentation URS FRS
Microsoft Office proficiency
Nice-to-have
LIMS and MES familiarity
Strong attention to detail
Cross-functional collaboration skills
Gap analysis experience
Willingness to learn in regulated environment
Key Requirements
Bachelor of Technology degree
1-3 years experience in CSV or Instrument Qualification
Experience with HPLCs, GCMS, or laboratory equipment qualification