I&D Operational Excellence Specialist
Location: Mumbai, India
Category: Regulatory Affairs
Primary Function
Manage training and governance for Innovation & Development (I&D) functions, including Medical, Clinical, Product Development, and Regulatory.
Core Responsibilities
Training Management
Ensure implementation of training activities for I&D functions.
Support maintenance and use of I&D Learning Management Systems (e.g., ISOtrain).
Manage and maintain I&D training matrices and curricula.
Prepare and upload content, create courses in training systems.
Prepare onboarding packages and assign trainings in the system.
Act as super user for systems such as ISOtrain, DARIUS, and I&D Training Matrix Platform.
System setup of ISOtrain records including profile creation, curricula assignment, and other related activities.
Liaise with Quality Group to prepare I&D quality system documents.
Governance & Compliance
Support compliance and quality control activities for global I&D functions.
Track and conduct self-inspection activities per departmental requirements.
Update department quality and compliance metrics.
Ensure I&D records comply with global guidelines and applicable regulations.
Perform quality control review of documents (content consistency, pagination, spelling, grammar, referencing, formatting).
Support internal and external inspection activities as required.
Position Accountability / Scope
Lead I&D training activities.
Conduct document quality control reviews and self-inspection activities.
Collaborate with internal stakeholders: Integration & Strategic Excellence, Medical Affairs, Clinical Development, Pharmacovigilance, I&D Quality, Regulatory Affairs, Product Innovation & Development, Office of Ethics & Compliance (Global, Regional, Local).
Coordinate with external stakeholders: business partners, contractors, consultants, vendors.
Qualifications
Education:
Post Graduate Diploma in Quality Assurance for Food and Pharmaceutical Industry
OR Bachelor’s / Master’s in Life Sciences
Experience:
Minimum 6+ years in Quality Management System and Training Management
Experience in training management for large groups preferred
Proficiency in Excel for metrics analysis
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Frank Scottile Blvd |Missouri :
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China | Quarry Bay |Liaoning :
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Netherlands |Remote Australia :
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Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Sheffield |Oxfordshire :
Witney |Ontario :
Renfrew | Mississauga | North York | Australia | Richmond Hill | Uxbridge |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
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Zaventem |South America :
Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
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Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Japan | Saitama |Tokyo :
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Brentwood |Bucharest :
Bucharest |Buenos Aires :
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New Mexico | Ciudad de México |Dubai :
Dubai |Makkah :
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Kyiv |Lima Region :
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Paris | Lyon |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
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