Swen Oswald

Support for one of the leading Digital diagnostics Companies

• Responsibilities:
• Lead the validation efforts for one of the biggest digital transformation projects implemented in the organization
• Supported and defended over 30+ regulatory and customer audits
• Assured consistent quality of operations by implementing and enforcing automated practice systems.
• Conducted risk assessments to identify and mitigate potential quality
• Increased efficiency by over 30% in validation projects by implementing Quality by design approach
• Developed and Implemented validation strategy for various tools based on Generative AI technology
• Trained and guided onsite and offshore team members in quality assurance standards, policies and procedures.
• Managed large-scale projects and introduced new systems, tools, and processes to achieve challenging objectives.
• Consistently met or exceeded annual performance targets set by senior leadership.
• Conducted performance evaluations, compensations and hiring to maintain appropriate staffing requirements.

• Responsibilities:
• Created a framework for efficient Test management, which increased team efficiency by 30%
• Collaborated with cross-functional teams to develop and implement process and system improvements.
• Developed quality planning for multiple new applications by verifying business requirements and implementing controls in design and production.
• Cross-trained existing employees to maximize team agility and performance.
• Maximized performance by monitoring daily activities and mentoring team members.
• Onboarded new employees with training and new hire documentation.

• Qualification of Cloud based services for one of the leading Pharmaceutical companies
• Responsibilities:
• Created, Reviewed/Approved Validation deliverables like Service Delivery plan, URS document, Risk Assessment, Validation summary report. Organized CSV boot-camp Training for 30 resources.
• Created Retirement Plan, Data Migration Plan for Legacy System Retirement Project.
• Streamlined the Review process which reduced review time by 30%.
• Single point of contact for all the testing related Metrics.
• Reviewed and Approved Testing deliverables and defects related to testing as QA lead.
• Member of team responsible for creating Deloitte Point of Views on Emerging technologies .

• Global Implementation of Product Lifecycle Management for one of the leading Pharmaceutical Company using Agile Methodology
• Responsibilities:
• Developed Risk Based Framework in Agile Methodology which was later incorporated into Client's QMS.
• Performed Gap Analysis on Client's Regulatory requirements with respect to FDA, EMEA, MHRA .
• Created Sharepoint tracker which helped in reducing the turnaround time by 20%.
• Mentored and Trained a team of 40+ resources for User Acceptance testing.