Quality Assurance Coordinator

57127 - Quality Assurance Coordinator

Position Includes:

Responsibility for the implementation and maintenance of all activities at the site that ensure the quality of systems, products manufactured at the site, and products marketed from the site. Providing ongoing support for all processes and departments at the site to ensure the implementation of the business strategy and work plans with quality goals.

Main Responsibilities:

• Approving documents - engineering files, parameter reports, batch records, protocols and production reports, stability reports, approvals of primary/advanced raw material suppliers, analytical methods and specifications, and validations of analytical methods and specifications.
• Approving changes in production systems, production processes, and analytical methods, excluding significant changes that require prior approval from the site quality assurance manager.
• Conducting internal audits according to an approved plan, producing reports, and tracking the implementation of corrective actions.
• Preparing annual reviews according to procedure.
• Informing the site quality assurance manager of issues that may impact product quality and summarizing the issues in detailed reports.
• Approving investigations, including corrective and preventive actions, excluding significant investigations that require prior approval from the field manager.
• Approving the rejection or release of raw materials, intermediate products, active ingredients, or finished products following a laboratory investigation related to the quality of the material.
• Ensuring the availability of an up-to-date document package for the process.
• Approving product releases from the plant.
• Approving stability reports and retest periods for finished products.
• Handling customer inquiries, including complaints, reviews, and various service requests.
• Handling inquiries from authorities received through the registration department.
• Any other duties assigned by the supervisor according to the company's needs.

Your Experience and Suitability for the Position:

1. Academic degree in chemistry/engineering/life sciences/natural sciences - mandatory.
2. Experience in a similar role - mandatory.
3. Background in the pharmaceutical industry - an advantage.
4. Organizational skills, service orientation, assertiveness.
5. Good level of English - writing and reading.