Quality Assurance

Biocon Biologics Limited, a subsidiary of Biocon Limited, is a fully integrated global biosimilars organization. It is leveraging cutting-edge science, innovative tech platforms and advanced research & development capabilities to lower treatment costs while improving healthcare outcomes. It has a strong research pipeline of biosimilar molecules across diabetes, oncology, immunology, and other non-communicable diseases. Six molecules from Biocon Biologics’ portfolio have been taken from lab to market in developed markets like United States, EU, Australia, Canada and Japan. With a team of ~ 4,800 people, Biocon Biologics is committed to transforming healthcare and transforming lives by enabling affordable access to millions of patients’ worldwide.

Education: minimum bachelor degree
Experience: 6-8 years with pure microbiologist experience especially investigation related.

Job Responsibilities

• SOP preparation for Quality Assurance.
• Reviewing SOP of other departments especially Quality Control Microbiology documents (Procedures/ Reports/ Protocols/ Study).
• Participating in Peer Review Meeting for Quality Assurance and Quality Control Microbiology documents.
• Coordinating meetings for related cross functional teams for Peer Review.
• Review of Change Management pertaining to Quality Assurance and Quality Control Microbiology.
• Training of cross-functional teams and QA Personnel on Quality Assurance procedures.
• Review and Approval of batch specific Environmental and Personnel monitoring reports.
• Periodic checks for EM and PM monitoring during the execution.
• Participate and Review Quality Management Systems such as Out of Specification, Out of Trend, CAPA, Change Management, and Deviations.
• Conduct periodic Laboratory rounds in Microbiology section for compliance.
• Audits:
• Internal: Coordinating internal audits, and be part of the audit teams.
• External: Be an SME for QA procedures and Investigations.
• Review and Approval of Equipment/Instrument Qualification/Re-Qualification/ Calibration and other associated documents within Microbiology section.
• Support to provide Quality Control data for regulatory filing as per requirements.
• Review and Approval of Method Validation, Method Verification and Method Transfer protocols and reports.
• Review and Approval of Water, Environmental and Personnel monitoring trend reports.
• Review and approval of raw data, reports and trends from Stability studies.
• Any other assignment given by reporting manager.
• Review and Approval of microbiological test reports and batch COA.
• Review and Approval of OOS and OOT trend reports.
• Handling of issuance of documents, and archiving of documents related to Quality Assurance and Quality Control Microbiology (as applicable).

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Your application will include the following questions:

• What's your expected monthly basic salary?
• Which of the following types of qualifications do you have?
• How many years' experience do you have as a Quality Assurance Role?
• How many years' experience do you have in a quality assurance (QA) role?
• How many years of auditing experience do you have?
• How many years' experience do you have in a quality control (QC) role?
• How many years' experience do you have with change management?