Quality Assurance Associate
- רמת השרון
- משרה קבועה
- משרה מלאה
- Create Standard Operating Procedures (SOPs) and other documentation related to the company's activities as appropriate.
- Overall responsibility for assuring the quality of the products released in Israel.
- Ensure that import, transportation, receipt of products, storage, and distribution are following the required level of quality (e.g. GDP, GMP) and local regulations.
- Maintain a Corrective Action and Preventive Action (CAPA) system to monitor the implementation of any corrective or preventative actions resulting from the investigation of complaints, product rejections, non-conformances, recalls, deviations, audits, regulatory inspections and findings, and trends from process performance and product quality monitoring.
- Provide support to the Qualified Person (QP) with decisions related to the quality of the products at the suppliers, and customers, including receipt and return of the company's products.
- Understand and keep updated with pharmaceutical regulations in Israel and updated SOPs published from time to time.
- Mediate between authorities and company management and manufacturing sites.
- Perform periodic Management Reviews and address any issues that may arise during the review.
- Ensure continual improvement of the quality system.
- Maintain packaging materials and all connected documents following Packaging Material S.O.P.
- Ensure that external audits are performed for the relevant functions.
- Control and investigate deviations regarding the products.
- Bachelor's degree in a related field (Pharmacy, Chemistry, or Biology).
- Minimum 3 years of experience in quality assurance in a pharmaceutical company.
- Strong understanding of Israeli and European regulatory requirements.
- Strong attention to detail and problem-solving skills.
- Excellent verbal and written communication skills.
- Ability to work independently and as part of a team.
- Strong computer skills, including experience with Microsoft Office and quality management systems.
- Ability to prioritize and manage multiple tasks effectively.
Mploy