Responsibilities:
- Provide Computerized System Validation (CSV) / Computerized System Assurance (CSA) consulting services for pharmaceutical and medical device Manufacturing company.
- Manage SDLC (system design life cycle) including risk, deviation and change managements (e.g., conduct risk impact or functional assessment(s))
- Ensure Good Documentation Practices, working with policy and procedural governances, assessments, plans, reports etc.
- Develop and execute FAT/SAT test scripts, qualification protocols and reports based on industry best practices and Client’s / Solution Provider’s documentation system.
- Review, analyze and evaluate system functions and processes to deliver validation deliverables.
- Develop approach using science- or risk -based approach that meets regulatory expectation.
- If a Senior member of the team, serve as Lead for CSV service in one or more of the following disciplines:
- Production/Manufacturing System (e.g., MES, DCS, Historian)
- Laboratory Instruments/Equipment/Enterprise system (e.g., LIMS, Empower)
- Engineering/Automation (e.g., BMS, Delta V)
- Emerging technologies (e.g., SaaS platforms, Cloud system)
Requirement:
- Bachelor’s degree in technical discipline such as Engineering, Science or IT. Graduates of related discipline may also apply.
- Possess 2 or more years of experience performing CSV activities.
- Experience in engineering / process automation such as DCS, Delta V, Historian, MES and/or PLC would be viewed favorably
- Ability to communicate quality and risk-related concept to technical and non-technical audiences
Interested candidates please apply online or send your latest CV to [email protected]
AlwaysHired Pte Ltd
Reg No: R1549345
EA: 24C2293
