Associate Director

7 days ago

India Biocon Full time

Department DetailsRole SummaryExternal Supply QualityKey ResponsibilitiesTake 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 QualificationsRequired Education Qualification M Pharma Required Experience 16 - 18 years

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