our company offers hope to patients suffering from rare and severe diseases by forming partnerships with emerging biotech companies to accelerate access to highly innovative therapies in international markets. As the creator and leader of the global partnership category in the pharma industry, we strive to be Always Ahead and work relentlessly to bring therapy to patients in need, no matter where they live. Our values are at the core of every action we take, and we are committed to going above and beyond to benefit the patients we serve. We are a dynamic, fast-paced company operating in over 34 countries on 5 continents. We are looking for out-of-the-box thinkers, people who are passionate, caring, agile, and adaptive, to join us on our mission. If you are looking to make a difference in people's lives, we invite you to join us! We are looking for a Quality Assurance Specialist to join our team. In this role you will be Supporting the quality activities throughout the product lifecycle, while ensuring compliance with applicable regulations, company procedures, and quality standards. Participate in routine quality oversight, process reviews, continuous improvement activities, and other duties assigned by management *Please note, the internal title for this role is Quality Assurance Specialist, Israel. *This is a one-year temporary position.
Responsibilities:
Responsible for coordinating and supporting quality activities across the organization, with two primary focuses: Logistics Center Quality, and Systems and Compliance Quality. The role ensures that products and quality processes are managed in accordance with applicable regulatory requirements, company procedures and quality standards throughout receipt, Storage, handling, customization and distribution activities, while supporting the effectiveness of quality systems through documentation management, training, investigations, CAPAs, risk assessments, audits, supplier oversight and continuous improvement initiatives. The position collaborates closely with operational and cross-functional teams to maintain compliance, product quality and business continuity, and performs additional duties as assigned. Quality- Logistics Center:
* Handling quality complaints
* Reporting deviations
* Replying to queries from customers
* Approving NPP forms (Certified pharmacist only)
* Managing and supervising packaging customization processes (relabeling)
* Transfer of products from non-tradeable stock to tradeable stock status, with a valid batch certificate signed by QP (Certified pharmacist only)
* Transfer of returned products to tradable stock status (Certified pharmacist only)
* Handling of rejected products according to internal SOPs and QPs instructions
* Handling customer product complaints - includes contacting the of complainant and reporting to the manufacturer/supplier
* Control of product destruction
* Managing narcotics and following all regulations related to narcotics (Certified pharmacist only)
* Carry out any task requested by the responsible pharmacist Systems and Compliance Quality:
* Ensure that the quality assurancesystem is implemented in a way thatthe approved activities can be managed.
* Ensure precision and quality were listed and approve inspected documents.
* Supervising that employee training is implemented and maintained.
* Handle changes, deviations, CAPAs, and audits according to the company's requirements. Implement preventative and corrective measures when necessary.
* Ensure implementation of periodic management survey.
* Ensure implementation of risk management.
* Ensure that vendors and partners are approved and qualified.
* Approve every activity performed by the subcontractor that may indicate the quality of the
* products.
This position is open to all candidates.