QA Ra Specialist

hace 4 semanas

Bogota, Colombia Werfen A tiempo completo

**Job Overview**:

- Post Date
- June 4, 2024
- Number
- WEBCO-2024-000007
- Job Function
- QA&RA
- Location
- Bogota
- Country
- Colombia

**About the Position**:
Job Summary

Support the implementation and execution of regulatory and quality plans, and perform any regulatory activities for products marketed by Werfen.

Key Accountabilities
- Support RAQA management with a business focus.
- Ensure compliance with RAQA record management processes.
- Lead and manage non-conformities, follow-up plans for CAPAs.
- Document tracking and control in SAP.
- Regulatory submissions to INVIMA and other regulatory entities.
- Preparation and updating of quality agreements.
- Internal customer document management.
- Management of regulatory and quality databases.
- Follow-up on regulatory processes with the factory.
- Follow-up and preparation of meeting and committee minutes.
- Provide technical and sanitary product documents.
- Issue letters to customers.
- Review registration requests received in detail and provide appropriate responses and support to stakeholders.

**Managed Budget (if applicable) & KPI**
- Ensure timely submission of regulatory dossiers.
- Track regulatory plans and quality assurance planning (audit plan, training plan, document management plan, change management, and risk management).
- Generate improvement proposals, continuous development, and involvement in projects.

**Internal Networks/Key Relationships**

To be determined based on departmental needs, including interactions such as:

- Customers
- External suppliers (logistics operator, certifying entities, INVIMA, ANDI, agen)
- Marketing managers
- Department managers/directors
- General Manager
- Commercial team
- Specialists and technical support team
- Clinical specialists

**Skills and Abilities**:

- Analytical skills
- Numerical analysis
- Problem-solving
- Statistical knowledge
- Negotiation skills
- Leadership, empowerment
- Communication skills
- Systems management (MS Office, Internet, etc.)
- Creativity
- Excellent interpersonal skills
- Customer focus
- Integrity
- Innovation approach
- Good organizational skills
- Ability to work under pressure
- Teamwork
- Good interpersonal skills and a good listener
- Negotiation skills
- Proactivity
- Results-oriented

**Minimum Knowledge and Experience Required for the Position**:

- Education: Higher education in Pharmaceutical Chemistry, Bacteriology, Biomedical Engineering, or Chemical Engineering.
- Experience: Minimum of 2 years of experience in Quality Assurance and Regulatory Affairs in the Medical Device and/or RDIV industry.
- Additional skills/knowledge:

- Computer skills, including Word, Excel, and PowerPoint.
- Language: Intermediate English.
- Knowledge of ISO 13485 and/or ISO 9001-2015.

**International Mobility**:

- Required: 10%

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