Manufacturing Operations Lead
1 week ago
At Syngene International Limited, we are seeking a highly skilled Lead Manufacturing Operations professional to join our team. As a key member of our operations team, you will be responsible for ensuring the highest standards of manufacturing compliance and quality for Oral Solids (tablets, pellets, capsules, and liquid-filled capsules).
Key Responsibilities:
- Ensure all Oral solids manufacturing and packaging is audit-ready and compliant with cGMP and regulatory expectations.
- Manage QMS documentation, including review of change controls, deviations, investigations, CAPA, OOS, OOT, customer complaints, APQR, validation protocols, and study protocols.
- Actively review the implementation of the Quality Management System (QMS) within the function to ensure processing activities are conducted in accordance with QMS requirements and current regulatory and quality standards.
Requirements:
- 18+ years of experience in manufacturing operations in Oral Solids, with Injectables experience being an added advantage.
- Regulatory audits from FDA, EMEA, Health Canada.
- Expertise in conducting thorough investigations, CAPA management, OOS.
- Strong analytical capabilities to assess compliance data and identify trends.
- Proficient in Oral Solids product manufacturing and process troubleshooting.
About Syngene International Limited:
Syngene is an innovation-led contract research, development, and manufacturing organization offering integrated scientific services from early discovery to commercial supply.
We prioritize safety at every level, with a strong commitment to following safety guidelines, procedures, and SOPs. As a Syngene employee, you will be part of a dynamic team that fosters a collaborative environment and encourages open communication and accountability.
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