Job Title: Executive - USP
Purpose of Job
To support and maintain quality systems, documentation practices, equipment qualification, and operational compliance within the CGT and BBM manufacturing facility. The role is crucial for ensuring regulatory adherence, proper documentation of operations, coordination with cross-functional teams, and execution of upstream manufacturing and buffer/media preparation as per GMP and data integrity guidelines.
Skill Required
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Sound knowledge of GMP/GxP compliance and data integrity (ALCOA+ principles)
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Expertise in SOP, protocol, and technical document preparation and control
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Experience with equipment qualification (IQ/OQ/PQ) and performance verification
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Familiarity with training and document control systems (e.g., TMS)
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Hands-on exposure to buffer/media preparation and upstream processing
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Proficient in QMS activities: deviation handling, change control, CAPA
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Understanding of internal audits, inspection readiness, and compliance documentation
Roles and Responsibilites
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Prepare, maintain, and update SOPs, protocols, logbooks, and other documents for CGT and BBM areas.
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Handle TMS software and ensure accurate documentation and training records.
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Coordinate with cross-functional teams (QA, QC, Engineering, Vendors) for equipment qualification and compliance.
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Conduct internal compliance checks and ensure adherence to defined quality systems.
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Support QMS-related activities, including deviation management, audit handling, and closure of internal quality audits.
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Archive and distribute documents as per SOPs and ensure document version control.
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Prepare and manage documents related to equipment qualification (SOPs, protocols, and reports).
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Ensure implementation and compliance with data integrity and good documentation practices (GDP).
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Train new employees and support staff as per defined training modules.
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Prepare and execute media and buffer preparation activities as per production batch records.
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Participate in upstream operations for commercial, clinical, and validation batches.
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Document all batch operations accurately and in compliance with written procedures.
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Provide support during internal and external audits, including document readiness and query resolution.
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Perform any other responsibilities assigned by the supervisor.
Qualification Required
MSC/MTECH Biotechnology
Biotech, Ahmedabad, GJ, IN, 382213