Biocon Pharma Limited is seeking an Associate Manager to join the team. In this critical role, you will be responsible for implementing and maintaining robust quality standards, ensuring full regulatory compliance, managing quality audits and documentation, and driving continuous improvement within our pharmaceutical manufacturing environment.

What You'll Do

Establish and maintain a robust Quality Management System (QMS) aligned with international standards (GMP, GCP, GLP).
Ensure all processes and procedures comply with regulatory guidelines from agencies like the FDA and EMA.
Manage the creation, review, and control of quality documentation for accuracy and adherence to standards.
Evaluate and implement changes to systems, processes, or products in a controlled, systematic manner.
Identify and assess risks in quality processes and products, developing mitigation strategies.
Lead initiatives to optimize quality processes, enhance efficiency, and drive a culture of continuous improvement.
Provide training and guidance to employees on quality processes and QMS requirements.
Conduct thorough investigations into quality deviations, non-conformances, and complaints to identify root causes.
Develop and implement effective Corrective and Preventive Action (CAPA) plans.
Contribute to continuous improvement of the QMS by identifying trends and opportunities.
Ensure preparation of Site Master File, Quality Manual, and Organogram.
Prepare and review Annual Product Quality Review (APQR) reports and initiate necessary changes.
Handle Change controls, deviations, risk assessments, and CAPA Management.
Review and approve change controls, deviations, CAPAs, and related documents.
Handle failure investigations, market complaints, and product recalls and returns.
Prepare and review trend analysis of quality system parameters.
Conduct Internal Audits/Self Inspections and ensure compliance action plans.
Schedule, conduct, review, and document Management Review Meetings.
Handle Customer/Regulatory Audits and provide timely responses to observations.
Ensure audit compliance and verify effectiveness of implemented CAPAs.
Review and approve all Master documents (SOPs, OIs, BMRs, BPRs, Validation Protocols/Reports, Stability Protocols, etc.).
Ensure effective and timely escalation of failures to management.
Supervise and monitor day-to-day activities of quality assurance and review team performance.
Train team and CFT teams on Good Manufacturing Practices, Data Integrity, and other relevant topics.
Ensure monthly reports are generated and reviewed.