Job Description

Job Description

Job Description

ROLE: Quality Supervisor

ATTRACTIVE SKILLS/EXPERIENCES:

• Bachelor’s Degree in Chemistry, Biology, Engineering or other related field
• Experience (5+ years) in a leadership role, preferably in a Quality Dept/Team
• Experience (3+ years) with product/process investigations, validations, and instrument qualifications
• Proven knowledge of cGMP and ISO Standards (ISO9001; 14001; 15378)
• Proven knowledge/usage of MS Office applications, SAP and electronic QMS systems
• Experience in pharmaceutical or glass forming industy (preferred)
• Demonstrated communication skills (written / oral) including the ability to read/speak English
• Ability and willingness to work in fast-paced, matrix structured organization

SUMMARY / RESPONSIBILITIES: This Quality Supervisor oversee the Quality Department and serve as the deputy-in-charge for the Site Quality Manager. Help with daily operations and overall department strategic planning. Support all quality teams through policies, procedures and accountability measures designed to ensure adherence to regulatory compliance, along with applicable performance standards. Foster and maintain alignment to current Good Manufacturing Practices (cGMP) and applicable ISO systems. Assist in the attainment of short and long-term department strategies and goals, along with reporting on Key Performance Indicators (KPIs), as needed.

Other potential duties/expectations include (but not limited to)…

• Lead, coach, and motivate employees within respective area of responsibility, while providing direction to achieve departmental goals and site objectives
• Cultivate employee talent through training and coaching measures, while also conducting employee performance reviews, along with interviewing for new hires
• Perform validation and re-validation of sterilization processes, including new cycle development with contractor(s) and annual reporting
• Manage the validation process, including process improvements for the site, along with the laboratories and Validation Master Plan execution
• Establish process for trending and monitoring of relevant quality KPIs such as the EM process, raw materials and finished product testing
• Perform site based risk assessments
• Support and manage the development and updating of Quality Assurance programs, policies, processes, procedures, and controls, including but not limited to the CAPA and Change Control processes
• Review, analyze and report on quality discrepancies related to SCHOTT products, while developing disposition and corrective actions for product discrepancies Manage and coordinate department training activities and projects
• Manage document control activities including- releasing, archiving, tracking, and reporting of the document review process for controlled documents
• Lead and support the implementation of systems and compliance improvements including site compliance, along with data integrity requirements
• Oversee the internal audit function to ensure ongoing compliance to the Quality Management System (QMS)
• Manage assigned CAPA(s) by performing root cause investigations, while defining resolution actions; implement preventive and corrective actions in a timely manner as a result of customer complaints or customer audit findings
• Assure compliance with ISO certifications and cGMP, along with adherence to Company policies and procedures and Code of Conduct/EHS safety guidelines

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