As a Quality Assurance Specialist, you will play a crucial role in ensuring the quality and integrity of our products. Your primary responsibility will be to oversee the implementation and maintenance of quality systems, ensuring compliance with regulatory requirements and company policies.
Main Responsibilities:
* Oversight of site inventory of Quality Agreements to ensure timely updates and approvals
* Management of Annual Reviews (AR/APR/PQR) for products and systems, including automation, to meet schedule deadlines
* Review and approval of Site Quality documentation, including Site Master File, Validation Master Plan, policies, or procedures
* Quality oversight of site application User Access Reviews, ensuring compliance with site and company policies
* Management of annual quality council schedule, agenda, minutes, and action follow-up
* Participation in investigation and review of internal/external customer complaints and supplier complaints in accordance with agreed lead-times
* Review and ongoing maintenance of site licenses, providing site documentation to support product filings as needed
* Assurance of accuracy and integrity of data and information through timely review programs
Requirements:
* Minimum degree or post-graduate qualification in Science, Pharmacy, or Engineering field
* Familiarity with global engineering standards, plant procedures, and policies
* Knowledge of computer applications, including Word, Excel, Access, eLogs, File and Email Management, Meetings Management, Technical report writing, Time management, Analytical Problem solving skills, Continuous improvement skills, Leadership, Communication skills, and Facilitation skills
Preferred Qualifications:
* Experience in IT Quality Assurance and SAP change control
Contact Information: Available upon request