Develop, review, and maintain Quality Manuals, SOPs, forms and related quality documentation.
Ensure the Quality Management System (QMS) is effectively implemented, maintained, and continuously improved in compliance with GDPMD requirements.
Coordinate and monitor QMS activities, including document control, corrective and preventive actions (CAPA), and continuous improvement initiatives.
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Receive, process, assess and report adverse events, product complaints and other safety information in accordance with local and global regulatory requirements.
Ensure Individual Case Safety Reports (ICSRs) are complete, accurate and submitted within regulatory timelines.
Perform follow-up activities to obtain complete and medically relevant safety information.
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Work closely with internal and external stakeholders (i.e. Pharmacovigilance, Marketing, Quality Assurance, Finance, Regulatory Authorities) to ensure all the responsibilities and agreed services for the clients are met.
Understand and adhere to company’s regulatory affairs SOP
Full understanding on the business models and key processes related to Zuellig Pharma’s operations and structure that will affect services and responsibilities
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