Quality Assurance and Pharmacovigilance Associate

About the job

We are looking for a Quality Assurance and Pharmacovigilance Associate to join our team at K.S.KIM International (SK Pharma) Ltd. The successful candidate will be responsible for providing support to the QA Manager in ensuring that the company is in full compliance with Israeli regulatory requirements, Good Manufacturing Practice (GMP), and all relevant regulations.

Responsibilities:

• 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.

Qualifications:

• Bachelor's degree in a related field (Pharmacy, Chemistry, or Biology).

• Minimum 2 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.