Hybrid Senior Manager - BEU (Tumkur) bei SAP Business Technology Platform

Qualifications

• Masters in Pharmacy or equivalent
• Min 15 to 20years’ demonstrated experience in quality assurance function in pharma &/ dietary supplements industry
• First hand experience of handling regulated markets like USA and EU is preferred.
• Experience of managing direct reports and collaborations globally with diverse teams
• In-depth understanding of analytical practices

Skills: 

• Team orientation, “can-do “attitude and ability to deliver breakthrough results
• Management of certifications like ISO, Halal, Kosher, USDA organic, FSSAI, EU organic etc.
• Art of negotiations, creative, follow-through -desired traits
• Ability to set up clear objective and priority-setting
• Knowledge of digital tools/processes/systems
• Proficient in written and oral communication in English

Responsibilities

• This position reports to the Unit head and comprises leading and managing QA function of extraction unit (located at Tumkur) producing extracts that are exported worldwide.
• Ensure quality compliance with internal and external stakeholders participation
• Participation in creation and control of quality documents (RM, PM, SFG, FG-specification, SOPs, STPs, GTPs etc.) adherence by internal auditing, deviation management
• Quality compliance as per company policy by working with internal and external stakeholders (internal company audits & external auditing agencies)
• Working with head of the Unit to ensure quality timely deliveries
• Continuous Quality Improvement program: Implementation of sound and up-to-date principles of GLP, cGMP and other industrial practices.
• Manage troubleshooting related to quality and relevant communications by participation in quality investigations within and outside organization
• Support local and global regulatory teams for queries.
• Prepare and submit relevant technical documents to the business hubs/centers
• Independently evaluate all practices, limitations and plan risk mitigation plan with stakeholders
• Addressing manufacturing concerns, failures, participation in RCA and CAPA implementation
• Assessing impact of global regulatory updates on the existing portfolio and coordinate with QC, l regulatory teams.
• Assessing customer happiness and drive quality improvement programs and ensuring overall success for the organization
• Participate with CFTs for qualification of sites/testing labs/vendors etc.