A viable enterprise professional with interest in compliance and value added strategy. Possess business and engineering knowledge of product and services in energy, information technology, financial, healthcare and non - profit organization industry. Gain skills in business related specialized software, with excellent communication, organizational and presentational skills. Can undertake difficult mandate and meet target deadlines. Commitment to quality, data integrity and superb innovation strategies to optimize processes, reduce waste and elevate efficiency. Well qualified for positions requiring strong computer, technical, behavioral, regulatory, development and post marketing competencies. Personal qualities include: analytical, innovative, customer oriented, flexible, fast learner, detail and team oriented. Work in a competitive international and fast-paced environment.
TRANSFERABLE SKILLS &CORE COMPETENCIES:
- Business Process Automation
- Organisational & Interpersonal Excellence
- Technical Writing & Research Report
- Continuous Process Improvement Numerical & Analytical intelligence
- Problem Resolution and Decision - Making
- Product Development & Launch
- Technical Support Competence
- Lean Systems
- Outstanding Customer Relations
- Quality Control and Regulatory Compliance
- Quality Assurance
TECHNICAL & SKILLS PROFICIENCY:
Computer Related: Microsoft Office 2000/2003/2007/2010 , Microsoft Exchange 2003/7, Windows 7 enterprise, SAP, Visio, MS Project 2010, SPSS, Outlook, SAP, IBM Lotus Note, AutoCAD, Windows Platform, MySQL, and Microsoft Access.
Business Related: Strategic thinking, Regulatory and Safety, Service center, Project management, Scientific, Team building and Matrix Structure, Mathematical, Clinical simulation, Audit and Risk management, Internal Audits
INTERN, Design, Monitoring & Evaluation Specialist
- Work with Program Effectiveness and Learning team.
- Review design, reports, questionnaires and data sets of relevant program documents.
- Contributes to project teams and responsible for timelines and deliverables.
- Conducts data cleaning and analysis.
- Engage in discussions on analysed data, draft reports based on feedback.
- Participate in brainstorming, conceptualization and documentation.
- Prepare Research protocols, evaluation reports and plans.
- Plans, designs, and participates independently in programs reviews.
- Performs performance management process and particular implications of the policy revision.
- Analyze survey and non survey data on program effectiveness
- Make sense of data pertaining international development programs
Business Compliance Analyst
Confidential, New York
- Apply various business capabilities solutions to analyze, and synthesize client operational problems to deliver value for customers.
- Provide partnership with customers and team in selecting the use of appropriate methodologies and applications to achieve the desire business and technical results.
- Assist in generating and delivering financial services for healthcare management support system to ensure company works within the regulations.
- Identify and proactively reduces operational risk.
- Review processes, monitor and evaluate system performance to improve overall delivery.
- Regularly interface with customers and facilitate executive briefings in all stages of project lifecycle. Convene with customers to develop their business strategies and implementation, roadmaps and planning initiatives.
- Built long-term quality relationships with clients by ensuring their utmost satisfaction.
- Received recommendations for opening new business opportunities
- Demonstrated keen expertise to ensure innovative and efficient use of business processes, people and technology
- Understand Medical Device OMS requirements and regulatory including Confidential CFR 21 820 and ISO 13485.
- Design change and document change control, process verification and validation methodologies.
- Verify conformance of processes and specifications are in compliance with contract Service and Operational Level Agreement.
- Implement all Quality standards and specifications required on time to achieve business objectives.
- Demonstrate various principles, standards procedures and current good manufacturing (cGMP) practices to ensure product quality and compliance.
- Track and analyze performance of various tests to evaluate quality at post production.
- Applied continuous process improvement tools such as: DMIAC, Lean SS, 5S. Pivotal in providing exceptional quality services to support operational excellence.
- Review Shop Floor Paperwork (SFP) of manufacturing and analytical batch. Develop Bill of Materials (BOM’s) for all new products.
- Coordinate / execute Package Test Plan input PERs (Package Evaluation Requests).
- Evaluate Quality standards for all new components.
- Liaise with warehouse, shipping department for coordination of timeline and project execution with external clients.
- Experienced Confidential regulatory, controlled clean room environment
- Team member for numerous successful Confidential and Internal Audits.
- Committed to quality of patients and company properties
Administrator, Human Resources
- Coordinate meetings as needed to initiate working sessions, resolve project issues.
- Promote continuous improvement by conducting, documenting, and communicating needs to the manager.
- Coordinate findings, conduct root cause analysis, and corrective action planning.
- Prepare and conduct informal and formal presentations.
- Knowledge of global regulatory requirements, submissions and guidance related to pharmaceutical industry.
- Liaise with Health and Safety manager for adherence to site safety, regulatory and project related issues.
- Provide administrative support to the operation, and HR activities.
- Responsible for co-ordination of projects.
- Knowledge of Human Resources duties