VALIDATION ENGINEER

Datametrics Software Systems

0 years

0 Lacs

Hyderābād

Posted:1 month ago| Platform: GlassDoor logo

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Skills Required

documentation installation management lims data capture software research manufacturing risk compliance gcp audits strategy support evidence integrity audit controls archiving

Work Mode

On-site

Job Type

Part Time

Job Description

Validation Engineer is needed to perform the following duties: : Draft, review, and execute validation documentation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols. Ensure validation efforts align with GxP, FDA 21 CFR Part 11, and GAMP 5 guidelines. Performing validation of computer-based systems such as Laboratory Information Management Systems (LIMS), Clinical Trial Management Systems (CTMS), and Electronic Data Capture (EDC) platforms. Validating software tools used in clinical research, manufacturing, and quality control processes. Conducting risk assessments to evaluate potential compliance gaps and identify critical control points. Ensure validated systems meet regulatory expectations of FDA, EMA, HIPAA, and ICH-GCP. Maintaining accurate validation documentation for audits and inspections. Manage change control processes related to system upgrades, patches, or modifications that may impact validated status. Work closely with Quality Assurance (QA), Regulatory Affairs, IT, and Operations teams to coordinate validation strategy and execution. Provide support during regulatory audits and inspections by presenting validation documentation and system evidence. Ensure that electronic systems handling clinical or manufacturing data preserve data integrity, including audit trails, access controls, and secure data archiving. Draft and revise Standard Operating Procedures (SOPs) related to system validation and compliance. Bachelor's Degree required in Pharmacy or Pharmaceutical Science or Pharmaceutical Engineering

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