Job Description

Department Details
Role Summary
External Supply Quality
Key Responsibilities
Take part in External Supplier's Qualification process, apply internal/ external intelligence to evaluate and facilitate the site due-diligence meeting /audit etc. and provide input to the management.

• Ensure the availability of the Quality agreements with all CMOs and service providers. Perform periodic reviews and amend previously existing Quality Agreements on as needed basis.
• Ensure that all aspects of the manufacturing Biocon Products at identified CMOs and Suppliers comply with the requirements of the Biocon Quality procedure, meet all relevant cGMP, regulatory and legislative requirements. Planning and executing of the Quality Audits of the CMOs/service providers as per planned calendar and closer of the same with appropriate response/CAPA.
• Co-ordination with CMO for evaluation of change control, deviations, complaints and OOS. Ensure CAPA are adequate and tracked till completion. Review of all Critical Quality Issues (deviations, complaints, recalls, counterfeits and product tampering, stability failures, etc.) according to the Quality Assurance Agreement and the Biocon Quality Procedure. Ensure investigations are correctly executed.
• Responsible for handling the quality aspects of recall and returned products in coordination with CMO's and CFT. .
• Provide direction and support to third parties (both local and global) to achieve a high level of competence. This includes regular site visits to local suppliers. Support CMOs for site readiness for regulatory inspections (FDA, MHRA, etc.) and during inspections when and where appropriate, in agreement with QTA.
• Support for regulatory filings pertaining to CMO projects. Participation in design of product development, scale up, regulatory batches and they are executed by following QBD principles, QRM, along with compliance to in house procedures and relevant regulatory requirements.
• To conduct the Quality Risk assessments for External Suppliers as and when required, to remediate the gaps identified in quality systems by monitoring the execution. Serve as member to Escalate all potential quality issues as per the Biocon escalation policy and to higher-level management, especially the ESQ Head and initiate appropriate actions as defined.
• Any other duties assigned by Head QA -ESQ.

Educational Qualifications
Required Education Qualification: M.Pharma
Required Experience: 16 - 18 years