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Quality Assurance Systems Specialist
hace 2 meses
Overview
The role involves overseeing the execution of internal and external audits in alignment with global regulations and standards.
Position Summary
This position is crucial for enhancing the organization's value by managing improvements in documentation and change order systems, ensuring compliance with relevant standards. The individual will play a key role in maintaining adherence to Quality System Management protocols.
Key Responsibilities
- Execute internal audits and engage in external audit processes.
- Drive continuous enhancements in Quality System Management.
- Design and oversee an electronic document and record management system (EDRMS) that complies with GMP and specific ISO regulations.
- Streamline the Change Management system utilizing the SAP change order module.
- Ensure all operations align with the Quality Management System.
- Report departmental metrics effectively.
- Provide direction and oversight to all direct reports.
- Determine departmental priorities.
- Facilitate internal follow-up meetings.
- Educate staff on new processes or enhancements related to Audits, EDRMS, or Change Order module functionalities.
Networking and Key Relationships
Interactions will vary based on departmental needs and may include:
- All company departments.
- Representatives from Notified Bodies and Competent Authorities.
- Counterparts in Quality Systems and Compliance at Werfen.
Required Knowledge & Experience
Education
- Required: Bachelor's degree in a relevant field.
- Preferred: Additional higher-level degrees.
Experience
- Minimum of 5 years of professional experience in a similar role.
Additional Skills and Knowledge
- Expertise in Internal/External Audits.
- Proficient in Office Tools (Microsoft), with required knowledge in SAP and EDRMS.
- Fluent in Spanish or Catalan, with advanced English proficiency (reading and speaking).
- Familiarity with Quality Regulations applicable to the organization.
Skills & Capabilities
- Ability to make agile decisions under pressure.
- Methodical and organized approach to tasks.
- Strong teamwork skills.
- Effective time management abilities.
- Clear and concise communication skills to ensure understanding among staff.
- Systematic approach to monitoring and verifying results.
- Collaborative and proactive participation in working groups.
- Reflects Werfen's values in work quality and relationships.
Travel Requirements
- Up to 10% travel may be required.
