What are the responsibilities and job description for the QA Compliance Specialist position at TekOne IT Services Pvt. Ltd.?
Role: QA Compliance Specialist
Location: Columbus, Ohio
Duration: 12 Months on W2
Shift Timings: 8:30 AM to 5:00 PM
What You’ll Do
Location: Columbus, Ohio
Duration: 12 Months on W2
Shift Timings: 8:30 AM to 5:00 PM
What You’ll Do
- Manage and optimize the process to implement approved Regulations and Standards in terms of monitoring, assessing, and ensuring change management and change control activities are timely and adequately completed.
- Cross-functionally remediate current and future regulatory impact on the quality system.
- Ensure project scope is clearly defined: develop and manage project plans to meet deliverables.
- Manage cross-functional project timelines and follow up with project team members to ensure timely completion of tasks.
- Responsible for identifying and managing critical project issues and risks, and timely communication to senior leadership.
- Provide clear and consistent communication, both oral and written to all project stakeholders on key project elements such as scope timeline, issues, etc.
- Understand and support AN Commercial QA and Quality Assurance Compliance organizations and opportunities for improvements.
- Integrate key AQR/AN QA initiatives as appropriate, based on compliance risk and availability of resources and business processes to support.
- Process changes to policies, procedures and systems that will ensure AN and market compliance requirements are met.
- Recommend and implement strategies and enhancements to improve efficiency.
- Develop and maintain effective KPIs that enable key success factors.
- Coordinate Quality Intelligence operations and business cycle updates
- The quality and compliance of AN products is a competitive advantage in the marketplace, and any lessening of our standards or not meeting market requirements can have an adverse long-term impact on our business. This position will work with limited supervision.
- Education and experience you will bring: Required
- Bachelor’s degree in a relevant discipline/or equivalent work experience is required (Business
- Administration, Chemistry, Microbiology, Food Science, Engineering).
- 5-7 years in a regulated nutritional food-manufacturing environment, preferably pediatric or medical nutrition products, in a Quality, R&D, Project Management, Procurement or Operations
- function and good knowledge of food cGxP and nutritional regulations.
- Knowledge in nutritional manufacturing controls and quality systems.
- 3-5 years experience in project leadership roles.
- Critical thinking/problem-solving skills.
- Ability to plan and facilitate meetings.
- Effective Stakeholder Management.c
