Job detail for QC lab team supervisor

Organization/Overview

The Quality Control organization is part of the site Quality Management, supporting the Csanyikvölgy Pharmaceutical Manufacturing site. Quality Control performs the testing and release of incoming materials, the testing and qualification of waters used on-site, and is responsible for in-process testing, hygienic monitoring of cleanrooms, and the qualification of semi-finished and finished products. Activities performed in Quality Control are in accordance with regulatory and registration requirements, as well as Sanofi's internal standards.

**Main **

• Overseeing the daily operations of the Quality Control laboratory to ensure adherence to committed schedules.

• Maintaining the laboratory in accordance with GMP and Quality Control processes defined by internal and external quality requirements and registrations.

• Ensuring the use of validated methods in their area and executing any validation/transfer protocols as a receiving unit.

• Managing and training laboratory personnel, ensuring they adhere to best practices and safety guidelines.

• Ensuring that laboratory personnel are qualified to perform testing by maintaining the laboratory qualification matrix.

• Conducting laboratory operational routines to identify opportunities for improvement.

• Ensuring accurate and timely testing of received samples according to their scope.

• Reviewing and approving laboratory test results and reports.

• Maintaining laboratory equipment by applying maintenance, qualification, and calibration plans to ensure the accuracy and reliability of laboratory activities.

• Investigating and resolving Quality Control incidents, issues, or deviations in their area in a timely manner. Implementing corrective actions from findings and CAPAs.

• Ensuring that their laboratory/facilities and laboratory instruments are in a quality and safe condition so that they can be used properly.

Part 3: Key involvement in the decision-making process

Key Roles (D,A,I)

• Defining and prioritizing laboratory quality control goals (A)

• Contributing to protocol development and execution (e.g., validation, transfer, testing) (A)

• Developing training programs (D)

• Advising on testing schedules and priorities (A)

• Deciding on the approval of test results (D)

• Advising on equipment maintenance schedules (A)

Part 4: Local specifics

**Additional **

• Writing Quality Specifications and local documents.

• Professional management of ordering materials and tools required for work.

• Ensuring the maintenance of measuring instruments and maintaining their controlled status.

• Verifying test results in primary documentation and the Laboratory Information Management System (LIMS).

• Investigating Out of Specification (OOS) results, deviations, and market complaints, and managing changes.

• Performing qualification tasks.

• Preparing validation protocols and reports.

• Immediate reporting of observed irregularities to the professional supervisor and participation in handling irregularities.

• Observing and enforcing hygiene rules.

• Providing reliable data to partner units.

• Obliged to perform work in accordance with Quality Assurance, GMP, occupational safety, and valid procedures.

• Observing and enforcing Data Integrity rules at the site.

• During work, obliged to perform activities in accordance with current Good Manufacturing Practice (cGMP) regulations, and site-specific Standard Operating Procedures (SOPs) and work instructions issued based on Sanofi corporate policies and recommendations.

• Making suggestions for improving activities that are part of the job, in the spirit of the Lean approach.

• During work, obliged to fully comply with prescribed corporate, occupational safety, fire safety, environmental protection, property protection, and other safety regulations and provisions.

• Responsible for attending prescribed training and acquiring the knowledge available there in order to remain suitable for filling the given position/role.

• Participating in prescribed GMP training and acquiring the knowledge available there.

• Cooperating and sharing information with colleagues, and striving to maintain a productive workplace atmosphere.

• Observing occupational safety, fire safety, environmental protection, and property protection rules and provisions. Warning colleagues and immediately reporting observed dangerous situations to their supervisor to reduce risk.

• Appearing at the workplace in a condition suitable for work and performing work in accordance with occupational safety training. The employee is obliged to cooperate with colleagues and perform work in a way that does not endanger their own or others' health and physical integrity. Regularly checking the condition of personal protective equipment before starting work and using them as intended.

• In the event of a malfunction, error, or unexpected situation, warning colleagues and taking measures to eliminate it as expected or reporting it to their supervisor. Obliged to immediately report accidents and near-miss situations that come to their attention. Obliged to participate in prescribed medical fitness examinations.

• Making suggestions for improving activities that are part of the job, in the spirit of the Sanofi Play to Win mindset.

• Initiating, supporting, and tracking problem-solving projects.

• Ensuring cooperation with internal and external partners related to the scope of tasks.

• Applying signature authorities according to DOA regulations.

• As part of the applied training system, participating as an instructor

• in the training of employees,

• in the organization and execution of training.

• Managing attendance sheets and other training records related to training.

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

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The salary range for this position is :Ft9 523 200,00 - Ft12 697 600

Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs.