Mary Joseph
Bangalore
Summary
Dynamic IT Validation & Compliance professional with extensive experience in project management and stakeholder engagement. Successfully implemented continuous solution monitoring in ServiceNow, driving regulatory compliance and supporting organizational change initiatives. Committed to delivering quality outcomes in the pharmaceutical industry.
Overview
15
15
years of professional experience
7
7
Certifications
Work History
IT Validation & Compliance specialist
Novonordisk, GBS
Bangalore
01.2018 - Current
- Implemented continuous solution monitoring in ServiceNow stemming from digitalization of IT periodic evaluation at Novonordisk as Project Manager/Product Owner in partnership with product team to uphold regulatory compliance.
- Managed qualifications of solutions according to regulatory requirements and business objectives.
- Specialized in computer system validation, project management, and organizational change management.
- Executed problem-solving strategies and process digitalization initiatives across various projects.
- Demonstrated expertise in stakeholder management and compliance advisory within pharmaceutical industry.
- Applied waterfall and agile methodologies to enhance project delivery.
- Documented quality deliverables to meet stringent compliance standards and facilitate audits.
- Coordinated quality and compliance documentation for Region Europe.
- Planned year wheel activities to enhance operational efficiency.
Associate Business Analyst
Novonordisk, GBS (Contract Position through Randstad India Private Ltd)
Bangalore
09.2017 - 12.2017
- Authored and reviewed quality documents, including system impact assessments and user review reports.
- Conducted IT security risk assessments and developed comprehensive IT security plans.
- Defined system specifications to align with project objectives.
- Managed personal data lifecycle documentation for GDPR compliance and governance.
- Performed periodic evaluations of IT systems to ensure operational effectiveness.
- Created audit support materials and inspection readiness checklists.
- Executed data integrity risk assessments and quality risk assessments to mitigate potential issues.
- Facilitated functional risk assessments to enhance system reliability.
Contract executive
Novonordisk, GBS (Contract Position through Randstad India Private Ltd)
Bangalore
01.2017 - 09.2017
- Streamline, retrieve, and normalize profile details of contracts across contract repository system
Intellectual Property Trainee
Novonordisk, GBS (Contract Position through Randstad India Private Ltd)
Bangalore
07.2016 - 12.2016
- Conduct Pharma Patent Search Services
Assistant Professor
Mets school of Engineering, Mala
Thrissur
10.2010 - 11.2015
- Coordinated M.tech Bioprocess Engineering program to enhance curriculum delivery.
- Managed B.tech and M.tech subjects, ensuring alignment with academic standards.
Education
M.tech Biotechnology - Biotechnology
Karunya University
08-2010
Skills
- Computer system validation
- GxP oversight and quality assurance
- Regulatory compliance
- Quality documentation
- Project management
- Stakeholder engagement and influence
- IT governance
- System application management
- Data integrity focus
- Audit support and CAPA effectiveness
- Team leadership and event coordination
- Organizational change management
- Knowledge transfer and communication
- Mentoring and training
Certification
SAFe 6 Product Owner/Product Manager
Affiliations
Toastmasters International
Timeline
IT Validation & Compliance specialist
Novonordisk, GBS
01.2018 - Current
Associate Business Analyst
Novonordisk, GBS (Contract Position through Randstad India Private Ltd)
09.2017 - 12.2017
Contract executive
Novonordisk, GBS (Contract Position through Randstad India Private Ltd)
01.2017 - 09.2017
Intellectual Property Trainee
Novonordisk, GBS (Contract Position through Randstad India Private Ltd)
07.2016 - 12.2016
Assistant Professor
Mets school of Engineering, Mala
10.2010 - 11.2015
M.tech Biotechnology - Biotechnology
Karunya University