Provides expertise in performing Computerized Systems Validation.
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.)
Perform collaborative work with the Compliance Engineering team on other CQV activities.
Coordinate with both internal and external teams (manufacturing, engineering, quality, vendors, contractors, etc.) to achieve the site objectives.
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 Engineering/Science or related studies.
Minimum of 10 years experience in relevant industry with at least 3 years in CSV activities.
High level of understanding in Regulatory compliance
Primarily responsible for supporting all computer validation aspects to the automation and engineering teams of Takeda.
This includes Domain Controller system (DCS), Manufacturing Execution system (MES), Manufacturing data warehouse (MDW), Building Automation Systems (BAS), GMP and non-GMP, Programmable Logic Controllers (PLC) based skids, IT infrastructure , standalone computerized system with equipment and validated spreadsheet
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.
In-depth knowledge in Computer System Validation (CSV), GAMP 5, 21 CFR Part 11, ER/ES, validation lifecycle, current Good Manufacturing Practices (cGMP) and
Good Documentation Practices (GDP) in a biotech facility
Good knowledge of GxP, GDP, CQV approaches including Validation Lifecycle approach (URS, DQ, FAT/SAT, IOQ, CSV, Cleaning/ Thermal Validation etc.), regulatory requirements and best industry practices.
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.
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.
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
Preferred who has training or Certification in Hardware and Fieldbus communication, Batch process Operations along with EPKS & TPS
