Investigator - 1592799

Customer: Bristol Myers Squibb

Project: Manatí Sustainability Compliance Plan- Oversight

Reporting Requirements: The Contractor shall provide progress updates in writing. The normal working schedule is 40 hours per week; pre-approval from client should be requested in case of additional hours per week.

Services: The Contractor will play a pivotal role in ensuring the highest quality standards are maintained in the manufacturing processes. Will collaborate with cross-functional teams to investigate deviations, anomalies, and incidents, ensuring compliance with regulatory requirements and internal protocols.

Key Responsibilities:

• Review and assess investigation reports related to manufacturing deviations, incidents, and anomalies, in accordance with regulatory guidelines and company standards.
• Collaborate closely with Quality Assurance, Regulatory Affairs, and other relevant departments to gather necessary information and insights for comprehensive investigations.
• Ensure timely completion of investigation reports, addressing root causes, corrective actions, and preventive measures to prevent recurrence.
• Analyze data and trends from investigations to identify potential areas for process improvement and efficiency enhancement.
• Provide guidance and training to staff involved in investigations, fostering a culture of continuous improvement and quality excellence.
• Maintain accurate documentation of investigation activities, outcomes, and resolutions in compliance with industry regulations.
• Participate in internal and external audits, offering insights and information related to investigations and corrective actions taken.
• Stay current with industry best practices, regulations, and trends related to investigations and quality assurance in the pharmaceutical sector.