Computer Validation Specialist

Job Role: Computer Validation Specialist

Location: Somerset, NJ

• Performs and leads computer system validation projects related to authoring and executing specifications and validation documentation for process equipment/systems, laboratory automated instruments/equipment, and systems according to the ISPE GAMP 5 Validation Life Cycle. Documents include Data Integrity Assessment, FDA 21CFR Part 11 and EU GMP Annex 11 Assessment, Computer System Validation Plan, System Requirement Specification (SRS), System Impact Assessment (SIA), Data Integrity Assessment (DIA), Functional Requirement Specification (FRS), Design Specification (Software and Hardware), Commissioning, IQ, OQ, PQ, Summary reports, Requirements Traceability Matrix (RTM), Periodic Review of Computer Systems and Audit Trail review.

• Ensure that the site Computer System Inventory list is maintained per corporate format and remains in its current state.

• As a Subject Matter Expert (SME), Computer System Validation Specialist should be a site computer system administrator for equipment and instrument computer systems.

• Generate validation protocols and summary reports in line with corporate guidelines procedures, cGMP, and ISPE GAMP guidelines and regulations.

• Generate a CSV validation plan detailing the scope of work and intent.

• Identify specific tests and requirements to be met in the IQ/OQ/PQ that address requirements.

• Ensure all work is in line with the site Validation Master Plan, regulations, procedures, and practices.

• Ensure that the site Validation Master Plan remains current and aligned with corporate policies as it applies to CSV policies/standards.

• Generate and maintain site Computer System Validation procedures in line with corporate guidelines, cGMP, corporate policies/standards and ISPE GAMP 5 guidelines.

• Lead and conduct validation activities in compliance with US and EU regulations, (regulations for all countries where have business) procedures, and EHS requirements.

• Review and execute Computer System Validation protocols to ensure compliance and adherence with corporate guidelines procedures, cGMP and ISPE GAMP guidelines and regulations.

• Write risks assessments and applicable test scripts according to GMP and 21 CFR Part 11 compliance guidelines and the Site Validation Master Plan.

• Liaise with manufacturing and laboratory groups in execution of the Validation program.

• Communicate Computer System Validation approaches and requirements during audits.

Please share your resumes at chaitanya@starkassociatesllc.com (or) Contact: 848-277-1023