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Quality Assurance Supervisor
2 months ago
The Quality Assurance Supervisor (Inspection and Service Centre) is responsible for overseeing daily operations within the Incoming Inspection and Service Centre, ensuring adherence to high-quality inspection standards. Key responsibilities include planning, executing, and documenting inspections of incoming goods and conducting technical evaluations of finished products. This role also supervises quality control activities in the Site Service Centre and manages the calibration process. Reporting directly to the Quality Control Manager, this position collaborates closely with the Operations and Warehouse teams. Below are the primary responsibilities and essential tasks associated with this role, along with additional duties as reasonably assigned by the Quality Control Manager. This is a dynamic, on-site position aimed at ensuring effective management of manufacturing and service documentation, as well as fostering collaboration with Operations and Quality teams.
Key Responsibilities
Under the guidance of the Quality Control Manager, the Quality Assurance Supervisor will:
- Ensure compliance with Good Distribution Practices (GDP) and Good Manufacturing Practices (GMP) within the Incoming Inspection and Quarantine areas by inspecting incoming materials against established specifications.
- Develop and maintain procedures and work instructions for incoming inspections.
- Lead the Quality Control Manufacturing team, ensuring timely assessment and release of pharmaceutical products.
- Design and implement enhancements to incoming quality control testing specifications and associated documentation.
- Initiate and drive measurable performance improvement initiatives.
- Formulate processes, procedures, and work instructions within the area of expertise.
- Oversee and maintain the calibration process.
- Provide quality oversight for the Incoming Inspection and Quarantine area.
- Serve as a Subject Matter Expert by keeping abreast of relevant procedures and specifications, including supporting external audits.
- Assist with additional tasks as directed by the Quality Control Manager.
Qualifications and Skills
- Proficient understanding of GDP and GMP regulations.
- Ability to create and document Standard Operating Procedures and Work Instructions/Specifications.
- Familiarity with inspection criteria and the interpretation of drawings/specifications.
- Experience in an incoming inspection environment for medical devices.
- Knowledge of SAP is advantageous.
- Familiarity with Master Control is a plus.
- Excellent written and verbal communication skills.
- Strong grasp of GMP compliance requirements in Quality Control.
- Meticulous attention to detail.
- Encourages a collaborative work atmosphere.
- Understanding of basic measurement tools (e.g., calipers, jigs, and gauges).
