Job Description110,000 professionals are working together to improve patient’s life and you can be one of them! This is your unique opportunity to become the Quality System, Compliance and Operations Manager at our department at Targu Mures. In this role you will coordinate the activities of the QSCO department within the Quality Department of the Sandoz SRL unit, ensuring the release of pharmaceutical products on the market under conditions that do not affect their quality, safety and effectiveness, as well as compliance with the rules of good manufacturing practice (GMP). You will ensure that the operation of the business is in accordance with the legal and regulatory requirements of GMP, as well as with the Novartis Corporation's Policies and Quality Manual.Please note the role requires a knowledge of Romanian language.Your key responsibilities:Your responsibilities include, but are not limited to:• Implement the local quality system that aligns with the company's standards, local regulations and all regulations in the respective countries where the products are marketed and ensure the state of preparedness for inspection and a high level of compliance• Represent the QSCO department before health authorities and auditors; ensure appropriate communication processes are established and implemented to enable proper exchange of information with key partners; ensure adequate and timely escalation to the management of the problems related to the quality of the products and system• Prepare activity and quality reports; coordinate the activity of the Quality Committee in accordance with the local procedure and the requirements of the Novartis Quality Manual and ensure the implementation of the actions established within this council• Supervise activities within the Complaints Board and Change Request Board of the site; ensure that the process of batch release is carried out in good condition in accordance with the applicable local legislation and GMP rules; implement quality management programs, including the quality risk management process ensuring the identification, management and review of the identified quality problems• Assure performance of quality trainings and staff awareness of the quality and compliance requirements and the quality management system; implement the provisions of the Novartis Quality Manual and monitor compliance from a quality point of view, including performing internal audits, evaluating quality indicators and participating in the evaluations carried out by the management and coordinate internal and external audit processes, including planning, establishment of audit teams, audit performance, drawing documentation and monitoring the implementation of corrective actions• Safeguard the quality of all cGMP's activities from an operational point of view; participate on or coordinate the committees on the investigation of complaints, withdrawals, returns of products; perform verification of the annual product analysis for the products for which Sandoz SRL is registered as a unit responsible for the release of the batches or holder of the Marketing Authorization• Provide integrated planning, prioritization and execution of activities through full synchronization with business requirements; ensure operation of the compartment in an efficient way and maintain an innovative approach based on improving productivity, implementing best practices and harmonizing standards and monitor and report specific performance indicators.n/a Diversity & Inclusion / EEO Minimum Requirements What you’ll bring to the role:• University Degree from accredited university in Chemistry or Pharmacy• Solid knowledge of Analytical Chemistry and Pharmaceutical Industry• Minimum 5 of years’ experience form Quality Control/ Quality Assurance/ Pharmaceutical products manufacturing from a production environment within the pharmaceutical industry. • Solid understanding of compliance, cGMP, analytical aspects, manufacturing, storage and transportation, and regulatory aspects of pharmaceuticals• Proficiency Level of Romanian and English (both verbal and written)Desirable requirements:• Familiarity with concepts and tools of lean philosophy and lean transformation projects• Excellent communication and people leadership skills
Quality System, Compliance and Operations Manager in Târgu Mureş
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