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AM / Manager - Production Documentation & Compliance @ Yadagirigutta

10 - 16 years

10 - 18 Lacs

Yadagirigutta

Posted:-1 days ago| Platform: Naukri logo

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Skills Required

Compliance Production Documentation

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities Manage and maintain all production-related documentation, including Batch Manufacturing Records (BMRs), SOPs, Logbooks, and Validation Protocols. Review and ensure timely preparation, issuance, and retrieval of GMP documents in accordance with cGMP and GDP requirements. Coordinate with the QA and Production teams to ensure documentation accuracy and completeness. Lead documentation readiness for audits (regulatory, customer, and internal). Support and coordinate the preparation of audit responses, CAPA documentation, and follow-up actions. Ensure timely updates and version control of SOPs and Master Manufacturing Records. Implement document control systems and ensure document security and traceability. Monitor change control, deviations, and incident documentation related to production operations. Ensure compliance with data integrity and documentation best practices. Collaborate with cross-functional teams to enhance regulatory compliance culture on the shop floor. Provide training on documentation practices, cGMP, GDP, and audit readiness to production staff. Maintain and track compliance metrics and drive continuous improvement in documentation practices. Participate in regulatory inspections and ensure the availability of relevant documentation. Preferred candidate profile In-depth understanding of cGMP, GDP, and regulatory audit requirements Experience in handling documentation for USFDA, EU, WHO, and other regulatory bodies Strong analytical and detail-oriented mindset Excellent written and verbal communication skills Proficiency in documentation systems and electronic document management (EDMS) Ability to train and mentor teams on compliance practices

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