favorite this postQA Manager- Regulatory Affairs (Noida)hide this posting
compensation: Upto Rs 20,000 to Rs.40,000 per month employment type: full-time
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• Should be aware of the regulatory affairs, compliances, government rules and regulations, related to the new product establishment and licensing.
• 3-6 years of experience in Biotech R&D.
• Responsible for validating the quality processes by establishing process specifications and quality attributes.
• Should be able to prepare quality documentation by collecting, analyzing and summarizing the information which may include standardized/failed processes, stability studies, validations and corrective actions.
• Needs to maintain and improve process quality through regulatory compliances, surveillance audits, investing complaints and collaboration with other members of management.
• Should be able to achieve quality assurance and operational objectives through strategic planning, review analysis, preparing action plans, implementing production, quality improvement, competing audits, determining system improvements and regulations.
• Should be able to accomplish regulatory certifications, licensing requirements and system upgradation as per govt. norms & policies with on sight process validation; within a specified period of time.
• Will ensure that all legal and regulatory standards are met, within the system.
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