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Hetero Labs Limited
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Asst.Manager / Dy.Manager - SCM, EU Market

Asst.Manager / Dy.Manager - SCM, EU Market

Hetero Labs Limited

5 - 10 years

|

0 Lacs

Hyderabad / Secunderabad, Telangana Telangana India

Posted:1 day ago| Platform: Foundit logo

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Skills Required

Ra eu markets

Work Mode

On-site

Job Type

Full Time

Job Description

Roles & Responsibilities: Monitor and track the quality release of pharmaceutical batches supplied to the EU market. Work closely with Quality Assurance (QA), Regulatory Affairs (RA), and Manufacturing teams to ensure compliance with regulatory guidelines. Coordinate with European partners to provide real-time updates on batch release status and address any quality-related queries. Maintain and update batch release documentation, ensuring accuracy and regulatory compliance. Assist in the review of technical agreements related to quality and regulatory requirements. Support the Regulatory Affairs team in responding to queries related to dossier submissions and compliance. Track and manage regulatory approvals, variations, and renewals in alignment with EU guidelines. Ensure timely reporting of batch release data to internal stakeholders and external regulatory bodies. Work closely with the supply chain and logistics teams to ensure seamless product availability in the EU market. Maintain records of quality deviations, risk assessments, and corrective actions related to batch releases. Qualification: 5+ years of experience in QA, RA, or related functions in the pharmaceutical industry. Strong understanding of EU-GMP guidelines, regulatory frameworks, and batch release processes. Excellent coordination and communication skills to collaborate with cross-functional teams. Detail-oriented with strong documentation and data management abilities. Proficiency in MS Office (Excel, Word, PowerPoint) and regulatory software tools. Ability to handle multiple tasks, meet deadlines, and work effectively in a fast-paced environment.

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