Specialist - DQA

Aurigene Pharmaceutical Services Limited; Hyderabad; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Aurigene Pharmaceutical Services Limited in Hyderabad seeks an experienced Development Quality Assurance professional to establish and improve quality systems across development operations. The role focuses on ensuring compliance for biologics development, process development, and technology transfer.

You will review and approve reports, manage CAPAs, audits, and vendor qualification, and provide quality oversight at external sites.

Qualifications

• M.Sc./M.Tech in Biotechnology, Biochemistry or related disciplines.
• 8-12 years of experience in Development Quality Assurance (DQA) or Biologics QA in biopharmaceuticals.
• Experience in QMS, vendor qualification, and technology transfer preferred.

Responsibilities

• 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 specifications and methods of analysis (MOAs).
• Review and approve clone development reports and related documents.
• Review audit trails for equipment and instruments.
• Issue, retrieve, and control development-laboratory documents including batch records and protocols.
• Review RCB establishment reports.
• Review characterization reports.

Skills

Quality systems

Documentation control

Regulatory compliance

Audit readiness

Biologics QA

Education

M.Sc./M.Tech in Biotechnology, Biochemistry or related disciplines

Job description

• 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.