What are the responsibilities and job description for the Quality Specialist US position at Tjoapack?
Quality Specialist (subject Matter Expert: Supplier & Customer Management)
Position background
The QA department is responsible for maintaining the Quality Management System, ensuring compliance with Good Manufacturing Practices and that every product is packed in compliance to the customers’ specifications. In this role as Quality Specialist, you will be part of the Quality team and responsible for a subset of the Quality Management System, such as:
- Document Management System
- Supplier qualification including supplier audits and Quality Technical Agreements
- Self-inspection
- Quality Management Review
- Deviation and Complaint handling
- Product Quality Review
- Continuous improvement projects
Your responsibilities
In this role, you report to the Director of Quality. You manage, execute and improve subsets of the Quality Management System (QMS). In addition, you are also responsible for the following:
- Act as Subject Matter Expert for the Document Management System, or Deviation Complaint process, or Self-inspection APR process.
- Review and approve deviations and CAPAs, initiate and own as needed.
- Manage customer complaints, implement corrective actions, collaborate with various departments to address systemic issues, and perform impact assessments for change controls affecting production or QA processes.
- Lead and participate in improvement initiatives and project management tasks, manage documents, and handle APR, CAPA[TF1] [IW2] , RA, and CC reviews.
- You participate in internal audits and lead as appropriate.
- Support audit planning and execute supplier and customer qualifications and audits, including writing reports.
- Set up and conduct GMP annual training while continuously implementing improvements.
- Own, review and approve QA related documents (e.g. SOPs, WI, Forms, Training). You perform GMP compliance checks/Gemba walks in production/warehouse
We will help you become successful in your new job with a customized development plan. At Tjoapack, we work hard, encourage innovative ideas, and give freedom to work independently.
Our working conditions include minimum of 9 paid holiday’s, Health Insurance on the 1 of the month after 30 days working, Basic Life Insurance, 401K Plan.
Place within the organization
Tjoapack is a global contract packaging organization (CPO) specialized in primary and secondary pharmaceutical packaging and supply chain management services. We’re dedicated to shaping the future of the pharmaceutical supply chain to be safer and more reliable for our customers and for patients. With more than 30 years of track record in contract packaging, we use our knowledge and experience to offer flexible solutions to our customers challenges and use the latest technologies to continuously improve our operations. We now supply products to over 45 countries across all continents.
As the Quality Specialist, you'll be part of the Quality Team, which is at the heart and head of our total quality vision and mission. It is the Quality Team responsibility to make sure that our people, processes, materials and machines work together to assure patient safety. You will report to the Director Quality US.
A TMA Analysis is part of the selection criteria.
