MOS Compliance Expert
As a MOS Compliance Expert at Merck, you will play a pivotal role in the Production department, especially in the Compliance field, by conducting critical and transversal complex investigations, ensuring data integrity, leading Corrective and Preventive Actions (CAPA), maintaining compliance with Good Manufacturing Practices (GMP), and overseeing classified environment monitoring activities. Your responsibilities will also include overseeing project quality, managing Change Control Processes (CCP), and leveraging your proficiency in both French and English.
Key Responsibilities:
* Conduct Complex and Critical comprehensive investigations into quality and compliance incidents, identifying root causes and implementing effective solutions.
* Take charge of leading and managing Corrective and Preventive Actions (CAPA) to address quality and compliance issues.
* Spearhead efforts to ensure data integrity and compliance with regulatory standards in all aspects of operations.
* Maintain compliance with Good Manufacturing Practices (GMP) and other relevant regulations.
* Oversee project quality to ensure strict adherence to quality standards and regulatory requirements.
* Manage Change Control Processes (CCP)
* Monitor classified environments to ensure compliance with security and regulatory standards.
* Utilize proficiency in both French and English to effectively communicate and collaborate with stakeholders across different regions.
Functie-eisenQualifications:
- Bachelor's degree in a relevant field (e.g., pharmaceutical sciences, chemistry, biology, or related field).
- 4 to 5 years of working experience in the pharmaceutical industry, demonstrating a strong background in compliance including investigations processes, Stakeholder management, and regulatory standards.
- In-depth knowledge of Investigation process, data integrity, CAPA, GMP and CCP.
- Proficiency in both French and English, with excellent written and verbal communication skills.
- Strong analytical and problem-solving abilities, with a keen attention to detail.
- Ability to thrive in a fast-paced, dynamic environment and collaborate effectively with cross-functional teams.
