Quality Assurance Specialist

Ankor Holding A.S.

Requirements & Qualifications

• Bachelor’s Degree (preferably from Life Sciences or Chemistry/Chemical Engineering and equivalent),
• At least 2 years of experience in a similar position preferably in a facility operated same business sector,

• Good command of GMP & GDP applications, quality management system requirements in the context of ISO 9001 and ISO 13485, and local regulations regarding health business,

• Advanced level of English knowledge (understanding, speaking, and writing).

• Good command of MS Office programs,

• Commit to customers, team-oriented, results-focused, good communication skills, analytical thinking, Self-motivated and well planned.

Main Responsibilities/Job Description

• Evaluation of post-market activities, CAPAs, deviations, contributing them by investigating, reporting, and giving feedback to related parties,
• Conducting the internal audit in the context of the Quality Management System,

• Participate in the Supplier’s, authority’s, and 3PL audits to be performed in the facility, prepare the CAPA plan related to the department after the audit (if necessary), and perform the actions according to the due date,

• Playing a strong role in teams related to improving the quality and decreasing the deviations throughout the company and contributing to the implementation of the decisions taken during the team meetings,

• Coordinating the activities of implementing, updating, controlling, and ensuring the continuity of the Quality Management System established within the framework of ISO 9001: 2015 and ISO 13485:2016,

• Reviewing the documents (Procedures, instructions, forms, lists, etc.) within the quality management system, creating new ones, and ensuring the implementation of procedures,

• Ensuring the coordination and communication related to quality and regulatory activities among the company, suppliers, customers, local authorities, and certification bodies.