Regulatory Compliance Specialist
4 weeks ago
Role Overview:
- Execute responsibilities as a Regulatory Compliance Specialist as stipulated in industry regulations.
- Examine documentation pertinent to production and quality assessment.
- Assist Quality Assurance leadership in overseeing the Pharmaceutical Quality Management System.
- Offer expertise on Quality issues to foster ongoing enhancements.
Primary Responsibilities:
- Guarantee adherence to current Good Practices (cGxPs), Standard Operating Procedures (SOPs), and regulatory mandates.
- Scrutinize batch records and Good Manufacturing Practice (GMP) standards.
- Validate batches for conformity with regulatory guidelines.
- Detect and propose enhancements to processes.
- Oversee outcomes and deviations, ensuring that responses align with regulatory standards.
- Support client requirements and regulatory audits.
Required Qualifications and Skills:
- Bachelor's degree in a scientific field or Quality Assurance discipline.
- Strong decision-making and analytical skills.
- Capability to adhere to deadlines and optimize workflows.
- Familiarity with EU and US GMP regulations.
- Exceptional communication abilities.
This position provides a chance to significantly impact the life sciences sector. Lonza is committed to ethical practices and environmental stewardship. Join us in addressing intricate challenges and enhancing lives globally.
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Regulatory Compliance Specialist
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Slough, Slough, United Kingdom Lonza Full timeRole Overview:Fulfill responsibilities as a Regulatory Compliance Specialist as outlined in industry standardsExamine documentation pertinent to production and quality assessmentAssist Quality Assurance leadership in overseeing the Pharmaceutical Quality Management SystemOffer expertise on Quality issues for ongoing enhancementMain Responsibilities:Guarantee...
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Slough, Slough, United Kingdom Lonza Full timeRole Overview:Fulfill responsibilities as a Regulatory Compliance Specialist as outlined in industry standardsExamine documentation pertinent to production and quality assessmentAssist Quality Assurance leadership in overseeing the Pharmaceutical Quality Management SystemOffer expertise on Quality issues for ongoing enhancementMain Responsibilities:Guarantee...
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