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.
- 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.
- 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.
- Documentation and Reporting:
- Maintain meticulous records of investigation reviews, findings, and outcomes.
- Prepare comprehensive reports summarizing investigation results and recommendations.
- 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.
- Continuous Improvement:
- Contribute to ongoing process improvements by identifying areas for enhanced efficiency and compliance.
- Participate in quality-related projects and initiatives.
- 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.
- 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.