Quality Assurance Director
hace 1 día
Gerresheimer AG seeks a highly skilled Quality Assurance Chief to lead the implementation and coordination of our Quality Management System (QMS) in accordance with industry standards.
Key Responsibilities
- Develop and maintain QMS processes and procedures to ensure compliance with regulatory requirements.
- Conduct internal and external audits to ensure adherence to QMS standards.
- Collaborate with cross-functional teams to identify and implement process improvements.
- Provide training and coaching to employees on QMS procedures and regulatory requirements.
- Develop and manage process performance KPIs and QMS metrics.
Requirements
- Chemical or related degree.
- 3+ years of experience in quality assurance or a related field.
- Knowledge of regulatory requirements, including NOM-059-SSA1-2015, NOM-241-SSA1-2021, CRF 21, and ICHs.
- Strong problem-solving skills and ability to analyze complex data.
- Excellent communication and leadership skills.
- English conversational level (B2).
- SAP and Microsoft Office proficiency.
About Gerresheimer AG
Gerresheimer AG is a global leader in pharmaceutical packaging solutions and drug delivery systems. We are committed to innovation, quality, and customer focus. Our team is passionate about making a difference in people's health and well-being.
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