Validation Engineer
5 days ago
PSC Biotech Corporation is a pioneering biotechnology consultancy firm founded in 1996, headquartered in Pomona, California, USA. With global operations spanning Ireland, India, Singapore, Australia, and the US, we serve over 350 clients across more than 23 countries worldwide.
Our mission is to provide innovative cloud-based software solutions for quality management and regulatory inspections, catering to the needs of pharmaceuticals contract manufacturing professionals and metrology services. We strive to deliver exceptional results, exceeding client expectations while fostering a culture of excellence.
Job Responsibilities- Develop and implement qualification/validation documentation and cycle development studies, adhering to established protocols.
- Evaluate and execute change controls, ensuring smooth integration into existing workflows.
- Analyse and resolve technical issues during study execution, leveraging expertise to optimise outcomes.
- Collaborate with production, maintenance, and quality teams to ensure successful execution of Cycle Development & Performance Qualification activities.
- Author and review technical inputs for quality notifications, ensuring accurate and comprehensive investigations.
- Conduct root cause analysis of system failures and substandard performance, using standard tools and methods to resolve machine and system issues.
- Promote continuous improvement through Lean Six Sigma methodologies, driving process enhancements and efficiencies.
- Represent the validation team at global technical forums, facilitating cross-functional collaboration and knowledge sharing.
- Ensure compliance with Global Policies, Procedures, and Guidelines, regulatory requirements, and cGMP throughout day-to-day activities and job functions.
- Accountable for compliance via documentation completion, risk assessments, corrective actions, participation in audits and inspections, and proactive issue highlighting.
- Support regulatory audits and submissions as required, upholding high standards of professionalism and attention to detail.
- Foster a safe and compliant culture, working collaboratively with colleagues to drive excellence and success.
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Validation Engineer
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