SCICLONE PHARMACEUTICALS INTERNATIONAL (SG) PTE. LTD.
Singapore, Singapore
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Establish pv quality management system
Manage gvp compliance in eu and china
Conduct pv audits and change control
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SCICLONE PHARMACEUTICALS is seeking a QA Manager/Senior QA Manager to oversee pharmacovigilance quality management systems and ensure compliance with regulatory requirements, primarily in the EU and China. The ideal candidate should possess extensive experience in pharmacovigilance operations and quality management, with a strong background in the pharmaceutical or biotech industries.
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Job Summary
The role involves establishing and maintaining a Pharmacovigilance quality management system ensuring full compliance with GVP and regulatory requirements.
Candidates will be responsible for managing PV controlled procedures, conducting audits, and handling inspections from health authorities.
Fluency in both English and Chinese is required to effectively communicate with Chinese-speaking stakeholders and review regulatory documents.
Matching Summary
Match Score: 75
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SCICLONE PHARMACEUTICALS is seeking a QA Manager/Senior QA Manager to oversee pharmacovigilance quality management systems and ensure compliance with regulatory requirements, primarily in the EU and China. The ideal candidate should possess extensive experience in pharmacovigilance operations and quality management, with a strong background in the pharmaceutical or biotech industries.
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Skills & Requirements
Must-have
Establish PV quality management system
Manage GVP compliance in EU and China
Conduct PV audits and change control
Handle PV inspections from Health Authorities
Nice-to-have
Experience in pharmaceutical or biotech environments
Strong communication skills for stakeholders
Ability to manage ad hoc tasks
Key Requirements
Bachelor degree in clinical medicine, pharmacy, or life science
7-9 years of PV operation or quality management experience
3-5 years of specific PV quality management experience
Familiarity with GVP and regulatory requirements for China and EU