Aftab Rahman - QA Operations Manager
Experience
QA Operations Manager
Novartis Technical Operations Austria
- Working as QA Operations Manager due to network transformation at Novartis.
Strategic Product Lead (SPL)
Novartis Technical Operations Austria
- Lead cross-functional product team in a matrix organization across Technical Operations, Global Drug Development, Global Drug Regulatory Affairs and Business Franchise (Commercial, Global Brand Team and Global Program Team).
- Support commercial brand strategy and optimize performance along the value chain by driving product strategic decisions with leadership team to ensure cost-effective, reliable supply across product lifecycle and inventory management.
- Coordinate, define and execute the product supply strategy, lifecycle management strategy, supply risk management and product roadmap to ensure robust, high quality and on-time supply together with SCM, QA, Tech Ops, Commercial Operations, Marketing and Development.
- Liaise with product manufacturing sites, ensuring optimal site allocation, DS manufacture, DP filling, packaging & devices.
Program Manager
Novartis Technical Operations Austria
- Responsible for managing major global programs and projects across disciplines and multiple manufacturing locations.
- Leading the cross-functional pharma product life cycle projects—launches, improvement projects, site transfers, pruning and divestments.
- Organize and lead high-performing cross-functional teams in the planning and execution of device and combination product (Biologics/Biosimilars) programs.
- Kick off project/transfer teams, remove barriers to success, realize opportunities, drive the definition of project milestones and ensure implementation accordingly to agreed timelines and allocated budget.
- Develop cost estimates, secure funding/resources through financial planning and long-range planning processes, manage the program per plan, report actual and forecasted spending and resolve financial variances.
- Identify potential risks and elaborate contingency plans as appropriate; communicate project progress and deviations.
- Ensure alignment with all the functions involved in strategic project management and in the risk assessment & management review process.
- Communicate the program execution strategy, deliverables and milestones to internal and external stakeholders maintaining a clear, consistent narrative to foster engagement, understanding and alignment.
- Collaborate with the program team to implement effective program governance structures, work breakdown structures, roles and responsibilities, integrated timelines and communication plans.
- Ensure avoidance of stock out and write off due to the ongoing projects.
- Participate in operational excellence projects.
- Ensure that programs and projects are technically and financially closed out upon completion and any on-going responsibilities are formally transferred to appropriate parties.
Global Product / Project & LCM Lead NTO
Sandoz GmbH
- Leading the strategic and life cycle projects for the anti-infectives platform.
- Running project and product review and consolidating the related events affecting supply availability and capacity.
- Ensure alignment with all the functions involved in the strategic project review and in the management review (e.g. strategy, sites, franchise).
- Align bridging-/contingency-stocks for change projects, transfers, pruning and divestment projects with responsible function.
Regulatory Affairs Manager
Sandoz GmbH
- Compiling dossier and reviewing CMC documents and processing regulatory submissions worldwide.
- Prepare regulatory strategy for development projects.
- Review and approval of various technical documents for the dossier.
- Collection and compilation of scientific justifications and responses to the deficiencies received from Health Authorities as well as customers.
- Responsible QA-RA person for the department; participate in preparation and finalization of SOPs and GOPs.
Head Regulatory Affairs and Pharmacovigilance
Agepha GmbH Austria
- Leading the regulatory affairs team (team of 5 people) and communicating with various stakeholders.
- Compiling, reviewing, and processing regulatory submissions and product dossiers.
- Review of adverse events, literature survey and compiling PSURs.
- Acting as Deputy QP.
- MA transfer and related activities within the EU, SmPC harmonization in countries like Iceland, Denmark, Sweden and Finland etc.
Regulatory Consultant
Pharmaconsult
- Alignment meeting with customers and define regulatory strategy and act as local regulatory contact for Health Authorities.
- Review of dossiers and technical documents before submission to the Ministry of Health (GCC Countries, Jordan and Lebanon).
- Responding to the technical queries from regulatory authorities and customers.
Research Executive (Scientist II)
Torrent Research Centre
- Participate in formulation development of generic tablet formulation.
- Preparation of technical documents for the dossier.
- Review and approval of technical documents like product development report, specifications, BMR, BPR, validation protocols & reports, stability protocols & reports, analytical test procedures, analytical test reports, packaging records etc.
Research Officer
Ind Swift Limited
- Participate in formulation development of generic products.
- Preparation of technical documents for the dossier.
- Review and approval of technical documents like product development report, specifications, BMR, BPR, validation protocols & reports, stability protocols & reports, analytical test procedures, analytical test reports, packaging records etc.
Industry Experience
See where this freelancer has spent most of their professional time.
Experienced in Pharmaceutical and Biotechnology.
Business Area Experience
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Experienced in Quality Assurance, Project Management, Operations, Finance, Product Development, and Supply Chain Management.
Skills
Lifecycle Program Mgmt
Supply Chain Project Mgmt
Strategic Project Mgmt
Brand Strategy
Trd Project Management
Demand/capacity Planning
Launch Preparation
Risk Assessment & Management Mitigation
Regulatory Cmc Expert
Qa Responsibilities
Leading A Team
Goal Oriented
Strategic Mindset
Excellent Interpersonal & Communication
Highly Flexible And Adaptive
Good Coordination Skills
Quality Focused
Critical Thinking
Sap
Artificial Intelligence Tools Like Chat Gpt And Copilot
Python Programming
Docu-bridge
Microsoft Office, Acrobat, Think Cell
Regulatory Software
Languages
Education
MCI
MBA · International Business Management · Innsbruck, Austria
Jamia Hamdard University
Master of Pharmacy · Pharmaceutical Chemistry · New Delhi, India
Jamia Hamdard University
Bachelor of Pharmacy · Pharmacy · New Delhi, India
Certifications & licenses
IBM Program “What Is Managing Complexity, Driving Product Data Science”
IBM
Digital Transformation Certification
Boston Consulting Group
Machine Learning For Product Managers
Duke University
Diploma In Intellectual Property Rights
WIPO Geneva
Statistics
Experience
Global Experience
Expertise
Qualifications
Profile
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