Responsibilities:
- Provides expertise in performing Computerized Systems Validation. Works with Engineers to develop Computer Validation Strategy, plans, protocols, reports, risk assessment, requirement traceability matrix etc for any new or change induced validation system / activities.
- Primary personnel for the qualification of Computerized Systems including Automation Systems (PCS 7, EMS, MES) and GMP equipment qualifications operating within the framework of regulations (GxP, 21CFR11, etc.)
- Creation and/or review of validation lifecycle documents: User Requirement Specification, Functional Specification, Risk Assessments, Validation Protocols (IQ/OQ/PQ/CPV) and Reports, Study Protocols and Reports, Requirement Traceability Matrix, CFR Part 11 assessment and validation submission dossier related to CSV
- Perform collaborative work with the Compliance Engineering team on other CQV activities.
- Prepare, review, and approve of SOPs and qualification-related documentations (protocols and reports)
- Ensure that the qualification strategy is sound and adhere to company standards and regulatory requirements.
- Investigate deviations and write deviation reports and findings.
- Raise and follow-up change control records.
Requirements:
- Degree in Computer Science, Engineering, Science or related studies.
- Minimum of 4 years’ experience in Computerized Systems Validation (CSV). Must have strong track record in developing Computer Validation Strategy, plans, protocols, reports, risk assessment, requirement traceability matrix etc for any new or change induced validation system / activities.
- Must have in-depth knowledge in Computer System Validation (CSV), GAMP 5, 21 CFR Part 11, ER/ES, validation lifecycle and Good Documentation Practices (GDP)
- High level of understanding in Regulatory compliance. Familiar with working in a GxP environment and keeping up to date with current GxP, with flexibility to change as needed due to new regulatory requirements and technologies, as relevant for clinical and commercial supply.
- Good knowledge of GxP, GDP, CQV approaches including Validation Lifecycle approach (URS, DQ, FAT/SAT, IOQ, CSV, regulatory requirements and best industry practices.
- With good fundamental technical knowledge of automation system such as Siemens PCS7, OSIPI or IT system to assist automation engineers in developing life cycle documentation.
- (Preferred) Applicant with training or certification in Hardware and Fieldbus communication, Batch process Operations along with EPKS & TPS.
