Regulatory Compliance Specialist
4 days ago
PSC Biotech Corporation is looking for a skilled Regulatory Compliance Specialist to join our team. In this role, you will be responsible for ensuring compliance with Global Policies, Procedures, and Guidelines, regulatory requirements, and current Good Manufacturing Practices (cGMP) throughout day-to-day activities and job functions.
The ideal candidate will have considerable experience in a comparable role, with operating as an individual contributor adding value to the business in a GMP manufacturing setting.
Responsibilities- Design, author, review, approve, and execute qualification/validation documentation and cycle development studies in accordance with established approval processes.
- Develop and execute change controls, ensuring seamless integration into existing workflows.
- Analyse and resolve technical issues encountered during study execution, applying expert knowledge to optimise outcomes.
- Collaborate with production, maintenance, and quality representatives 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, utilising 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, fostering 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, maintaining high standards of professionalism and attention to detail.
- Foster a safe and compliant culture, collaborating with colleagues to drive excellence and success.
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Regulatory Compliance Specialist
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The Municipal District of Carlow, Ireland PSC Biotech Corporation Full timeJob Description:The Regulatory Compliance Specialist will be responsible for supporting the Engineering Department in a GMP environment. This role ensures that objectives are effectively achieved, consistent with client requirements to ensure compliance, safety, and reliable supply to customers.Main Responsibilities:Direct and lead deviations, out of...
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Regulatory Compliance Specialist
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Carlow, Ireland Psc Biotech Corporation Full timeAt PSC Biotech Corporation, we are seeking a talented Regulatory Compliance Specialist to join our Engineering Department. In this role, you will play a crucial part in ensuring that our company's products meet the highest quality and safety standards.About UsPSC Biotech Corporation is a leading Biotech Consultancy firm with operations globally. We provide...
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Compliance Engineer
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Compliance Engineer
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Regulatory Compliance Specialist
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