Quality Assurance Manager

QA Manager with a pharma experience for a medical combination device

Position Description:

As the Quality Assurance Lead, you will play a pivotal role in ensuring that the company's pharmaceutical products adhere to Good Manufacturing Practices (GMP) as per Eudralex Vol. 4 standards. You will be responsible for overseeing all aspects of quality assurance within the facility, implementing, and maintaining quality systems, and driving continuous improvement initiatives.

Job Responsibilities:

Develop, implement, and maintain the Quality Management System (QMS) in accordance with GMP guidelines.

Conduct regular audits and assessments to ensure compliance with regulatory requirements and company standards.

Oversee the management of a compliant QC analytical laboratory.

Lead the review of change controls, ensuring thorough evaluation and documentation of all changes impacting product quality by the applicable risk management procedure.

Oversee the review and approval of validation protocols and reports to ensure compliance with regulatory requirements and industry best practices.

Manage the documentation control system, ensuring all records are accurate, up-to-date, and in compliance with regulatory standards.

Responsible for collecting periodical data analysis and conducting annual product reviews, communicating findings and recommendations to the management team.

Lead the periodical Management Review process, facilitating discussions on key quality metrics, compliance status, and continuous improvement initiatives.

Lead investigations into quality incidents, deviations, and non-conformances, implementing corrective and preventive actions (CAPAs).

Provide guidance and training to staff on quality procedures, protocols, and GMP requirements.

Stay informed about changes in relevant regulations and industry best practices to ensure continuous compliance.

Position Requirements:

Bachelor's degree in a relevant scientific discipline (e.g., Chemistry, Pharmacy, Biology) or equivalent.

Minimum of 10 years of experience in quality assurance roles within the pharmaceutical industry.

Thorough understanding of Good Manufacturing Practices (GMP) per Eudralex Vol. 4 and other relevant regulations.

Proven experience leading and managing quality systems, including audits and inspections.

Managerial experience