Investigations Consultant - 1592957

Customer: BMS, Manati 

Project: SCP Oversight

Position Type: Full-Time by contract with ProQuality Network

PO Number: 82297146

Reporting Requirements: The Contractor shall provide progress updates in writing amin activities performed on a weekly basis to ProQN. Contractor shall report all daily hours worked with activities, on the weekly report forms to be provided by ProQN and shall submit forms to ProQN on a timely basis on Monday’s before 5 PM. Any deviations observed will be properly documented, evaluated, and resolved to avoid any delays in the delivery of the project.

Services: The Contractor will support the oversight workstream as reviewer of investigations. 

Key Responsibilities:

1. Investigation Review:

• Thoroughly review and assess deviations, discrepancies, and incidents related to manufacturing processes.
• Ensure that investigations are conducted in compliance with regulatory standards and company policies.

1. Root Cause Analysis:

• Collaborate with cross-functional teams to identify root causes of deviations and discrepancies.
• Assist in developing effective corrective and preventive actions (CAPAs) to prevent recurrence.

1. Documentation and Reporting:

• Maintain meticulous records of investigation reviews, findings, and outcomes.
• Prepare comprehensive reports summarizing investigation results and recommendations.

1. Quality Assurance:

• Ensure that manufacturing processes are executed in accordance with Good Manufacturing Practices (GMP).
• Support quality control activities to safeguard product quality and patient safety.

1. Continuous Improvement:

• Contribute to ongoing process improvements by identifying areas for enhanced efficiency and compliance.
• Participate in quality-related projects and initiatives.

1. Training and Development:

• Stay up-to-date with industry regulations and best practices related to deviation management and quality assurance.
• Provide training and guidance to manufacturing personnel on investigation and CAPA processes.

Qualifications:

• Bachelor's degree in a scientific or engineering discipline, such as Chemistry, Biology, Pharmacy, or related field.
• Previous experience in quality assurance, deviation management, or pharmaceutical manufacturing is highly desirable.
• Strong analytical skills with the ability to critically evaluate complex data.
• Excellent communication and interpersonal skills.
• Knowledge of regulatory requirements, including FDA and international regulatory agencies.
• Detail-oriented and committed to maintaining the highest standards of quality and compliance.
• Ability to work collaboratively in a cross-functional team environment.