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Quality Assurance and Control Specialist

Companie Verificata

Adaugat: 3 zile în urmă

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Companie:
IVATHERM
Functia Jobului:
Medical & farmaceutic
Industrie:
Alte industrii
Locatie & Tipul Jobului:
Bucuresti | Program Full Time
Nivel experienta:
Junior
Descriere:

The Quality Assurance and Control Specialist will play a critical role in ensuring that Ivatherm’s products consistently meet the highest standards of quality and regulatory compliance. This position will oversee quality control processes from packaging materials procurement to final product release, working closely with production, research & development, and regulatory teams. The specialist will also be responsible for monitoring and improving quality systems and ensuring compliance with local and international regulations.

Key Responsibilities:
1. Quality Control:
- Perform and oversee testing of intermediate, and finished products to ensure they meet predefined standards.
- Checking the correctness of artworks and labels.
- Collaborate with third-party testing laboratories when required.
- Maintain meticulous documentation of quality control tests, processes, and outcomes.
2. Quality Assurance:
- Develop, implement, and monitor Quality Assurance (QA) systems and protocols to ensure compliance with both regulatory standards and internal guidelines.
- Perform audits of internal and external production processes, ensuring that all standard operating procedures are adhered to.
- Manage non-conformance reports and Corrective and Preventive Actions systems, ensuring any product deviations are properly addressed.
- Own the Quality Manual ISO 9001 and propose the quality training agenda.
3. Continuous Improvement:
- Identify opportunities for process improvements, quality enhancement, and cost-efficiency within the production and QA processes.
- Implement new quality control methodologies and technologies to enhance product quality.
- Provide training to all relevant staff on quality assurance procedures and good manufacturing practices.
4. Collaboration:
- Work closely with R&D, production, sales & marketing, and warehouse teams to ensure that quality considerations are integrated into all phases of the product (development, manufacturing, transport, storage, sales).
- Liaise with external partners, suppliers, and manufacturers to align quality objectives.
5. Risk Management:
- Conduct risk assessments related to product quality, safety, and compliance.
- Develop strategies to mitigate risks and ensure that all risk factors are continuously monitored and controlled.

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