Aurigene Pharmaceutical Services Limited
Website:
aurigeneservices.com
Job details:
Job Description (Biologics DQA)
Roles & Responsibilites:
- Establish, implement, and continuously improve quality systems.
- Review and approve method development reports.
- Review and approve method qualification reports.
- Review and approve method transfer protocols and reports.
- Review and approve specifications and methods of analysis (MOAs).
- Review and approve clone selection and development reports.
- Review audit trails for all applicable equipment and instruments.
- Issue, retrieve, and control development-laboratory documents, including batch records, logbooks, protocols, quality/technical agreements, and layouts.
- Review and approve RCB establishment reports.
- Review and approve characterization reports.
- Verify the receipt of clones and cell banks, including supporting documents, certificates, transit data-logger reports, and applicable test and characterization reports.
- Review experimental data recorded in the electronic laboratory notebook (eLN) for analytical, bioanalytical, process development, and cell-line development activities.
- Review and approve upstream, downstream, and formulation process-development reports.
- Review and approve consistency-batch summaries.
- Review and approve point-of-use (POU) study protocols and reports.
- Review and approve technology-transfer reports.
- Participate in client project meetings and provide quality support to internal and external stakeholders.
- Manage quality management system (QMS) activities for development operations, including change controls, incidents, customer complaints, corrective and preventive actions (CAPA), and quality risk assessments.
- Provide quality oversight for development project activities performed at external manufacturing sites.
- Conduct routine development-laboratory rounds to verify that facilities and operations remain in a compliant state.
- Review raw-material and packaging-material specifications and support material categorization for vendor qualification.
- Handling of vendor qualification.
- Review and approval of equipment / instrument qualification documents.
Qualification & Experience
- Qualification: M.Sc./M.Tech in Biotechnology, Biochemistry or related disciplines.
- Experience: 8-12 years of relevant experience in Development Quality Assurance (DQA), Biologics Quality Assurance, Quality Systems, or related quality functions within the biopharmaceutical industry.
- Prior experience in biologics development, analytical development, process development, technology transfer, QMS management, and vendor qualification will be preferred.
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