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Quality Assurance Manager
hace 2 meses
Job Title: Quality Assurance Manager
About the Role:
MCR International is seeking a highly experienced Quality Assurance Manager to join our team in Valencia. As a key member of our organization, you will be responsible for ensuring that all products comply with quality and safety regulations, and for leading the Quality Assurance department to ensure adherence to industry standards.
Key Responsibilities:
- Develop and Implement Quality Management Systems: Develop, implement, and maintain quality management systems in accordance with local and international regulations (GMP, FDA, EMA, etc.).
- Coordinate and Oversee Audits: Coordinate and oversee internal and external audits, ensuring compliance with established regulations.
- Manage the QA Team: Manage the Quality Assurance team, providing direction and support in resolving quality issues.
- Collaborate with Other Departments: Collaborate with other departments (production, R&D, purchasing) to ensure product quality from raw materials to final product.
- Develop Quality Training Programs: Develop and implement quality training programs for staff.
- Review and Approve Quality Documents: Review and approve standard operating procedures (SOPs), product specifications, and other quality-related documents.
- Investigate and Resolve Quality Issues: Investigate and resolve quality issues, implementing corrective and preventive actions as needed.
- Monitor Change Control and Risk Management: Monitor change control and risk management in production processes.
- Stay Updated on Regulatory Changes: Stay updated on regulatory changes and ensure company compliance with new requirements.
Requirements:
- Education: Bachelor's degree in pharmacy, Chemistry, Biology, or related field.
- Experience: Minimum of 10 years of experience in Quality in the pharmaceutical and/or Biotech industry.
- Knowledge and Skills: Deep knowledge of GMP, FDA, EMA regulations, and other relevant standards. Experience in team management and leadership. Excellent communication skills and ability to work in a team. Ability to make informed decisions and solve problems efficiently. Ability to lead new projects and work autonomously. Analytical skills and attention to detail.
What We Offer:
- Competitive Salary and Benefits: Competitive salary and additional benefits.
- Professional Development Opportunities: Professional development opportunities and continuous training.
- Dynamic Work Environment: Dynamic and collaborative work environment.
- Participation in Innovative Projects: Participation in innovative projects within the pharmaceutical industry.
