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Quality Assurance Systems Specialist
hace 2 meses
Overview
Position Summary
The role is pivotal in ensuring that both internal and external evaluations are executed in accordance with global regulations and standards.
This position is designed to enhance the organization by overseeing the improvement of documentation and change order management systems, ensuring they align with applicable standards. The individual will play a crucial role in maintaining compliance with the Quality System Management framework.
Key Responsibilities
- Execute internal assessments and engage in external evaluations.
- Drive continuous enhancements in Quality System Management.
- Develop, implement, and oversee an electronic document and record management system (EDRMS) that adheres to GMP and specific ISO regulations.
- Streamline the Change Management process utilizing the SAP change order module.
- Ensure all operations comply with the Quality Management System protocols.
- Analyze and report departmental metrics.
- Provide leadership and oversight to all direct reports.
- Prioritize departmental tasks effectively.
- Facilitate internal follow-up meetings within the department.
- Educate staff on new processes or enhancements related to Audits, EDRMS, or Change Order module functionalities.
Networking and Key Relationships
Interactions will be determined based on departmental needs and may include:
- All organizational departments.
- Representatives from Notified Bodies and Competent Authorities.
- Quality Systems and Compliance counterparts at Werfen.
Required Qualifications
Education
- Required: Bachelor's degree in a relevant field.
- Preferred: Additional advanced degrees.
Experience
- A minimum of 5 years of professional experience in a similar role is essential.
Skills and Knowledge
- Expertise in Internal/External Audits.
- Proficient in Office Tools (Microsoft), with necessary knowledge of SAP and EDRMS.
- Fluent in Spanish or Catalan, with advanced English proficiency (reading and speaking).
- Familiarity with Quality Regulations relevant to the organization.
Competencies:
- Capable of making agile decisions under pressure.
- Methodical and organized approach to tasks.
- Strong teamwork abilities.
- Effective time management skills.
- Clear and concise communication skills to ensure understanding among staff.
- Systematic approach to monitoring and verifying results.
- Ability to actively collaborate and coordinate with teams.
- Embody Werfen's values in work quality and interpersonal relationships.
Travel Requirements:
- Occasional travel, estimated at 5-10% of the time.
