Quality Assurance Director
hace 2 días
**About Us**
Gerresheimer is a leading global partner to the pharma and healthcare industry, committed to delivering innovative products of the highest quality and contributing to health and well-being.
**Job Summary**
We are seeking a highly skilled Quality Assurance Chief to join our team. As a key member of our organization, you will be responsible for implementing and coordinating our Quality Management System (QMS) in accordance with industry standards and guidelines.
**Key Responsibilities**
- Implementation and coordination of QMS in accordance with standards NOM-059-SSA1-2015, NOM-241-SSA1-2021, CRF 21, ICHs, and pharmaceutical industry guides.
- Qualifications: Chemical or QFB Degree, 3+ years of experience in the area, experience with AMEF, CAPA, change controls, internal and external audits, RAP (Annual Product Revision), etc.
- Knowledge of NOM-059-SSA1-2015, NOM-241-SSA1-2021, CRF 21, and ICHs related to the pharmacy industry.
- Familiarity with problem-solving tools (Pareto diagrams, Ishikawa, control charts).
- Statistical process control knowledge, development, and management of process performance KPIs and QMS.
- English conversational level (B2).
- Experience with SAP.
- Proficiency in Microsoft Office.
- Results-oriented.
- Strong decision-making skills.
- Assertive communication skills.
**What We Offer**
- Work Hours: 8:00 to 17:30 hrs.
- Benefits above the law.
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