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 [Confidential Information]
AlwaysHired Pte Ltd
Reg No: R1549345
EA: 24C2293
We regret to inform that only shortlisted candidates will be notified. Please note that your response to this advertisement will constitute informed consent to the collection, use and/or disclosure of personal data by AlwaysHired and its affiliates for the purpose of job application processing, career advisory, research and any other administrative purpose, in compliance with the relevant provision of personal data protection act.
