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About Abbott:
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.
Connect with us at www.abbott.com, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at http://www.facebook.com/Abbott and on Twitter @AbbottNews.
QUALITY SYSTEMS AND COMPLIANCE MANAGER-METAP
Developing and maintaining the Regional Quality Documents
- To Support the Quality Systems & Compliance Manager in managing regional Quality systems which aligns with EPD Division and Corporate Quality system requirements.
- To Support Quality Systems & Compliance Manager in preparation of the regional documents.
Compliance at Manufacturing Sites & Affiliates
- To ensure Implementation of AQ & EQDs at Region, Site & Affiliates.
- To support sites/affiliates for Audit readiness and in validation activities.
- To support Quality Improvement projects & remediation project across region
- To support regional team in reviewing Compendial Compliance and Regulatory Changes Notification
- To support Regional Internal audits at manufacturing site, region and affiliates
- To review high impact ER/Complaint investigations and provide scope of improvement by identifying gaps in the investigation report to prevent critical findings during audits
SolTRAQ coordinator
- To Act as Regional Coordinator for Exceptions and Complaints managed at regional level.
- To monitor the approval and ensure timely closure of the open quality indicators i.e. Deviations, Exceptions, Market Complaints, Change Control on regular basis by taking continuous follow-up with affiliates and manufacturing siteS
- Interact with Global IT for SolTRAQ data field updation.
Job Requirement-
Science Graduate/ Post Graduate with minimum 10 years relevant exp in Pharma industry
Experience in implementation of Quality systems and compliance
Should have auditing experience (preferably)
Good communication skills
Willingness to travel-20-25%