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- Ensure the safety message is lived throughout the organization, promoting a culture of safety.
- Coordinate document and record management systems; coordinate site document management requirements, including document printing, reconciliation, and archival.
- Ensure all documents follow approved instructions and that completed records are archived accurately.
- Coordinate site training and personnel qualification, improving GMP training modules.
- Ensure timely completion and efficiency checks of CAPAs.
- Manage corporate standards gap assessment, ensuring site compliance with regulatory requirements.
- Support and continuously improve the site self-inspection program, including developing annual plans, and performing periodic reviews and trend analyses.
- Coordinate inspection readiness activities, preparing the site for client and regulatory audits.
- Participate in audits, ensuring smooth execution and compliance.
- Adhere to and support the implementation of site data integrity systems.
- Complete any additional related tasks as assigned.
- Understand and ensure implementation of emergency procedures and safe work systems.
- Ensure compliance with environmental, health, and safety rules and prompt reporting and investigation of incidents.
- Education: Diploma or equivalent experience in Life Sciences, Chemical/Biochemical Engineering, or a related field.
- Experience: 1-3 years of relevant quality experience in pharmaceuticals preferred. Fresh graduates with relevant qualifications may be considered.
- Proficiencies: Understanding of cGMP and regulatory compliance, strong communication and collaboration skills, problem-solving capabilities, and knowledge of quality risk management.
- Ensure the safety message is lived throughout the organization, promoting a culture of safety.
- Coordinate document and record management systems; coordinate site document management requirements, including document printing, reconciliation, and archival.
- Ensure all documents follow approved instructions and that completed records are archived accurately.
- Coordinate site training and personnel qualification, improving GMP training modules.
- Ensure timely completion and efficiency checks of CAPAs.
- Manage corporate standards gap assessment, ensuring site compliance with regulatory requirements.
- Support and continuously improve the site self-inspection program, including developing annual plans, and performing periodic reviews and trend analyses.
- Coordinate inspection readiness activities, preparing the site for client and regulatory audits.
- Participate in audits, ensuring smooth execution and compliance.
- Adhere to and support the implementation of site data integrity systems.
- Complete any additional related tasks as assigned.
- Understand and ensure implementation of emergency procedures and safe work systems.
- Ensure compliance with environmental, health, and safety rules and prompt reporting and investigation of incidents.
- Education: Diploma or equivalent experience in Life Sciences, Chemical/Biochemical Engineering, or a related field.
- Experience: 1-3 years of relevant quality experience in pharmaceuticals preferred. Fresh graduates with relevant qualifications may be considered.
- Proficiencies: Understanding of cGMP and regulatory compliance, strong communication and collaboration skills, problem-solving capabilities, and knowledge of quality risk management.