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| Job Location | Mumbai City |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Recruitment Services |
| Functional Area | Quality (QA-QC) |
| EmploymentType | Full-time |
Working with the Life Sciences vertical and coordination with Regional QEHSS, country and area quality and HSSE leaders within India and related peers within the Global Quality organization, the Quality Manager will work to ensure the roll out and on-going compliance to Agility s quality and compliance systems, and associated procedures and standards. Engaging operations to maintain and implement the following management system/ guidelines as required in the various sites in the Agility India as directed from Operations and Regional QEHSS organization; o ISO9001:2015 (Quality Management system) o ISO 13485 - Quality Management System for Medical Devices o Good Distribution Practices (as per Annex 5, WHO good distribution practices for pharmaceutical products) o Good Storage Practices (Annex 9, Guide to good storage practices for pharmaceutical) o Guidelines on Good Distribution Practices for Pharmaceutical Products (Central Drugs Standard Control Organization (CDSCO)) o Occupational Health Safety Management system (OHSAS18001/ ISO45001) o Environment Management system (ISO14001:2015) Prepare Legal and other requirement register and work with the business to ensure compliance to with applicable statutory and legislative requirements Create, Analyse Non Conformance statistics on a monthly basis, working with the business to resolve, improve or mitigate exceptions. Supplier and Customer KPI s Monitoring as per Non Conformance Statistic and respective follow as per instructions received. Review QTA, business implementation periodic quality review with customers as per performance Non Conformity System maintenance in view of open NCR s. Monthly random check in view of validity, expiry date, document references on existing policies, process, templates, and quality system including information to APAC Quality Team in Singapore when updates are required. Working with APAC Quality Team based in Singapore to monitor, analyse implemented Corrective and Preventive Actions, Internal changes as per change control list.,
Keyskills :
management systemlife sciences iso 13485item response theory health safety managementpreventive actions qualityquality system