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Quality Assurance Manager
2 weeks ago
Currently, we are looking for a Quality Assurance Manager to join our highly motivated and inspired B2B team in Zentiva. Zent2U is a pharmaceutical B2B company focused on delivering high-quality medicines and therapeutic solutions to our partners across the globe. Our commitment to excellence, safety, and innovation is at the core of every product we deliver.
As a Quality Assurance Manager at Zent2U, you will be integral in upholding the company's reputation for delivering pharmaceutical products that exceed both industry standards and client expectations. You will lead quality assurance initiatives, streamline processes, and act as a beacon of expertise in all matters related to product quality.
What Would Be Your Main Responsibilities
- Quality Systems Management: Oversee the development, implementation, and maintenance of quality assurance systems and processes, ensuring compliance with global regulatory standards.
- Auditing: Oversee internal and external audits, identifying areas of improvement and ensuring corrective actions are taken.
- Change Control & Quality Technical Agreement Management: Oversee and manage the end-to-end change control process in accordance with regulatory and internal quality standards.
- Regulatory Compliance: Ensure all products meet the regulatory requirements of the countries in which they are distributed.
- Risk Management: Identify potential risks in product quality and develop strategies to mitigate them. Ensure that all CAPAs derived from deviations, product complaints, risks, audits, etc. linked with the B2B client's portfolio, are documented and executed/implemented.
- Continuous Improvement: Stay updated with the latest industry trends and best practices to continuously enhance the QA processes. Leads the Quality Assurance Agreement preparation & execution process.
- Stakeholder Communication: Act as the primary liaison for quality-related issues with both internal stakeholders and external partners.
- Reporting: Generate regular reports on QA activities, metrics, and trends to senior management. Is responsible for monitoring the performance of the quality system KPIs, linked to B2B activity.
- Cooperation and leading of a Quality Assurance Specialist
Other responsibilities
- HSE: Adheres to the principles communicated within the ESMS Policy of Zentiva detailed in the internal rules of the Company for the purpose of observing the rules of the Health & Safety at Work and the Environmental & Safety Management System.
- PHARMACOVIGILANCE: All employees are obliged to report any suspicion to adverse events of medicinal products, any adverse events concerning use of a medical device and any other safety inform.
- Communication & Working Relationship: both internal: All B2B functions, All Zentiva departments, Zentiva manufacturing sites and Zentiva Affiliates and external: Customer and Third Party/CMO.
We Need You To Have
- Bachelor's degree in Pharmacy, Chemistry, or related field. Advanced degree preferred.
- 3-5 years of experience in the pharmaceutical industry, with a proven track record in quality assurance roles.
- Extensive knowledge of GMP, FDA, EMA, and other relevant international regulatory standards.
- Strong analytical, problem-solving, and organizational skills.
- Excellent written and verbal communication skills.
