From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s blood donations to ensure a healthy supply, our purpose is to make the world a better place by bringing life-changing health technologies to the people who need them. That’s our commitment to helping you live your best life.
We understand that the first step to living your best life is good health. Everything we make is designed to help you do just that. That’s our commitment to building life-changing technologies that keep your heart healthy, nourish your body at every stage of life, help you feel and move better, and bring you information, medicines and breakthroughs to manage your health.
We create breakthrough products – in diagnostics, medical devices, nutrition and branded generic pharmaceuticals – that help you, your family and your community lead healthier lives, full of unlimited possibilities. Today, 114,000 of us are working to make a lasting impact on health in the more than 160 countries we serve.
Location India: Mumbai
Category: Quality
MAIN PURPOSE OF ROLE:
- Quality Systems review and effective Implementation: (30% of time)
Responsible for effective implementation of applicable Quality policy relevant to commercial affiliate Review and maintain site Quality Manual Review list of applicable regulations and support impact assessment on Quality systems. Ensure product action readiness all the time for commercial Affilaite Review and maintain product action procedure in accordance with applicable Quality policy and regulatory requirement. Review Quality Objectives and ensure Affiliate QA meet the Quality objectives. Review and support Affiliate Quality Management review process. Keep tracking of FSSAI license validity for applicable sites. Maintain approved distributor list.
- Regulatory compliance (20% of time)
- Purchasing Control (30% of time)
Coordinate regulatory visits, audits and its follow-ups. Coordinate regulatory compliance. Implement systems for Quality Metrics and drive improvements for the same. Ensure testing requirements for Import and Ex-India markets are followed. Coordinate Importation testing requirements and maintain record. Lead Temporary product reassignment activities for Affiliate Quality.Ensure compliance with requirements of OACA-SUP and other relevant procedures. Conduct monthly governance meetings and share meeting outcome and identified risks. Establish actions for each identified risk and ensure its timely closure. Prepare supplier audit schedule, supplier reevaluation plan and perform supplier performance monitoring ensuring compliance with relevant timelines. Supplier qualification including conduction of audits wherever required, revaluation and ASL update within relevant timelines. Conduct monthly review of relevant purchase orders, timely highlight identified risks and take necessary actions as applicable. Review Supplier corrective action request and ensure timely closure of the actions.
- Quality systems – Affiliate Internal audit program and CAPA (20% of time)
Ensure compliance with requirements of internal audit procedure and applicable OACA-CAPA procedures and guidelines. Draft, review, obtain approval and communicate Internal audit program. Facilitate pre-audit requirements up to audit closing meeting which includes documenting findings and report issuance. Ensure to upload audit findings into SBM CAPA system as applicable. Review audit schedule and track adherence. Conduct CAPA governance meeting, follow up with stakeholders for closure of assigned tasks, prepare CAPA dashboard and share updated dashboard on fortnightly basis. Support RCA and CAPA review with event owners to ensure compliance to relevant procedural requirements.
Experience Details:
- Team handling experience.
- Experience in implementation of Quality Systems
- Experience in handling regulatory and external audits
- Good analytical, communication and presentation skills
- Stakeholder management
- Sound knowledge over HACCP and Quality systems.
- Internal audit/ Lead auditor certification in ISO 9001, FSSC 22K/ BRC.
- Power BI and MS excel analytics.
- Proficiency in using quality management software and tools
Other License/Certification
Certification in ISO, FSSC 22000, Quality Systems
Preferably a lead auditor for FSSC 22000Explore Location
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