IPQA-Biosimilar

MJ Biopharm

4 - 9 years

5 - 9 Lacs

pune

Posted:1 hour ago| Platform:

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Skills Required

microbiology ipqa fermentation in process quality assurance apqr cleaning validation process validation

Work Mode

Work from Office

Job Type

Full Time

Job Description

Comprehensive knowledge of large-scale biotech manufacturing, covering both upstream ( fermentation) and downstream (purification ) processes.
Excellence in documentation for batch records and process-related documents to ensure accuracy, traceability, and regulatory compliance.
Proficient in cell bank management, including creation, storage, monitoring, and traceability for consistent production performance.
Advanced understanding of Good Manufacturing Practices (GMP), regulatory standards (including FDA), and pharmacopeial requirements for biotech products.
Strong communication, teamwork, and interpersonal skills to foster effective cross-functional collaboration and timely resolution of production quality issues.
Skilled in identifying, documenting, and investigating deviations, as well as executing root cause analysis and implementing corrective and preventive actions (CAPA).
Knowledge of process validation and preparation of Annual Product Quality Review (APQR) to ensure robust and compliant manufacturing operations.

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