Detalii loc de munca

Join our team as a Quality Assurance Consultant and play a pivotal role in ensuring the highest standards of quality and compliance within our organization. You will be responsible for maintaining and overseeing our Quality Management System (QMS) across local affiliates, ensuring adherence to regulatory requirements and company policies.

• Implement and maintain the QMS in local affiliates.
• Manage the local Quality Manual and Site Master File.
• Conduct quality risk management, including risk identification and control.
• Act as the Local Complaint Coordinator for complaint management.
• Oversee change control management and QA assessments.
• Handle deviation management for internal and external deviations.
• Manage CAPA from audits and inspections.
• Conduct authority inspections and self-inspections.
• Perform local GxP surveillance and assessments.
• Conduct product quality reviews (PQR).
• Manage training, including maintaining the training matrix and conducting GxP refresher training.
• Oversee local product release and shipment reviews.
• Ensure compliance with GDP requirements for warehousing and distribution.
• Manage shipping lane qualifications and transport performance.
• Handle return management and product recall execution.
• Manage GxP suppliers, including audits and CAPA approvals.
• Oversee local repackaging and relabeling processes.

Qualifications:

• Bachelor's degree in Quality Management, Life Sciences, or related field.
• Minimum 5 years of experience in Quality Assurance within the pharmaceutical or healthcare industry.
• Strong knowledge of GxP regulations and quality standards.
• Excellent analytical, problem-solving, and communication skills.
• Ability to work independently and collaboratively.
• Proficiency in Quality Management Systems and Learning Management Systems (LMS).

Key Competencies:

• Attention to detail and accuracy.
• Strong organizational and time management skills.
• Effective leadership and team management abilities.
• Proactive and results-oriented mindset.

We offer a competitive salary and a dynamic work environment where you can grow and make a significant impact.