Syqe Medical
- 29/11/2023
- טבריה
Syqe Medical Ltd. is a leading pharmaceutical cannabis facility dedicated to producing high-quality medicinal products. Committed to the highest standards of quality and compliance, we are seeking a dynamic and experienced Quality Assurance Lead to join our team.
As the Quality Assurance Lead, you will play a pivotal role in ensuring that our pharmaceutical cannabis products adhere to Good Manufacturing Practices (GMP) as per Eudralex Vol. 4 standards. You will be responsible for overseeing all aspects of quality assurance within the facility, implementing and maintaining quality systems, and driving continuous improvement initiatives.
Responsibilities:
- Develop, implement, and maintain the Quality Management System (QMS) in accordance with GMP guidelines.
- Conduct regular audits and assessments to ensure compliance with regulatory requirements and company standards.
- Oversee the management of a compliant QC analytical laboratory.
- Lead the review of change controls, ensuring thorough evaluation and documentation of all changes impacting product quality by the applicable risk management procedure.
- Oversee the review and approval of validation protocols and reports to ensure compliance with regulatory requirements and industry best practices.
- Manage the documentation control system, ensuring all records are accurate, up-to-date, and in compliance with regulatory standards.
- Responsible for collecting periodical data analysis and conducting annual product reviews, communicating findings and recommendations to the management team.
- Lead the periodical Management Review process, facilitating discussions on key quality metrics, compliance status, and continuous improvement initiatives.
- Lead investigations into quality incidents, deviations, and non-conformances, implementing corrective and preventive actions (CAPAs).
- Provide guidance and training to staff on quality procedures, protocols, and GMP requirements.
- Stay informed about changes in relevant regulations and industry best practices to ensure continuous compliance.
- Bachelor's degree in a relevant scientific discipline (e.g., Chemistry, Pharmacy, Biology) or equivalent.
- Minimum of 10 years of experience in quality assurance roles within the pharmaceutical or cannabis industry.
- Thorough understanding of Good Manufacturing Practices (GMP) per Eudralex Vol. 4 and other relevant regulations.
- Proven experience leading and managing quality systems, including audits and inspections.
- Strong analytical and problem-solving skills with the ability to drive process improvements.
- Excellent communication and interpersonal skills with the ability to work collaboratively in a cross-functional environment.
- Detail-oriented with a commitment to ensuring the highest levels of product quality and safety.
- Advanced degree (e.g., Master's or PhD) in a relevant scientific discipline.
- Experience in the pharmaceutical cannabis industry.
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