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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 audits are executed in accordance with international standards and regulatory requirements.
This position enhances organizational value by overseeing improvements in documentation and change order management systems, ensuring compliance with relevant standards. The individual will play a crucial role in maintaining adherence to Quality System Management protocols.
Key Responsibilities
- Conduct internal audits and engage in external audit processes.
- Drive continuous enhancements in Quality System Management.
- Design and oversee the electronic document and record management system (EDRMS), ensuring compliance with GMP and 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 and performance indicators.
- Provide direction and oversight to all direct reports.
- Prioritize departmental tasks effectively.
- Lead internal departmental follow-up meetings.
- Train 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 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 qualifications.
Experience
- A minimum of 5 years of professional experience in a similar role is essential.
Additional Skills and Knowledge
- Expertise in Internal and External Audits.
- Proficient in Office Tools (Microsoft), with required knowledge of SAP and EDRMS.
- Language proficiency: Fluent in Spanish or Catalan, with advanced English skills (reading and speaking).
- Familiarity with Quality Regulations applicable to the organization.
Skills & Competencies:
- Ability to make agile decisions under pressure.
- Methodical and organized approach to tasks.
- Strong teamwork capabilities.
- Effective time management skills.
- Clear and concise communication skills.
- Systematic approach to control, follow-up, and verification of results.
- Collaborative and proactive participation in working groups.
- Commitment to the values of Werfen in quality of work and interpersonal relationships.
Travel Requirements:
- Occasional travel, estimated at 5-10% of the time.
