CAPA Investigator - Contract
As an Investigator, you will be responsible for developing and leading comprehensive investigations within our CAPA (Corrective and Preventive Action) process. You will take ownership of the investigation phase, ensuring that issues are thoroughly analyzed and resolved while maintaining accurate documentation throughout the lifecycle of the investigation. You must have experience in pharmaceutical manufacturing.
Key Responsibilities:
- Develop and Present Investigation Plans: Create detailed investigation plans and present them to management or the CAPA review board.
- Define and Analyze Investigation Elements: Determine the Define/Measure/Analyze elements essential to the investigation.
- Scope and Lead Investigations: Define the scope of each investigation, assume ownership, and lead the investigation phase of a CAPA.
- Assemble Cross-functional Teams: Identify and recruit appropriate team members from various departments to form the Investigation Team.
- Implement Corrections and Containment: Confirm corrective actions and containment measures based on the investigation findings.
- Utilize Investigation Tools: Identify and apply suitable investigation tools to address the issue at hand.
- Source and Analyze Data: Determine the relevant data sources for the investigation and obtain the necessary data.
- Root Cause Analysis: Investigate and identify the root cause(s) of the issue.
- Document Findings: Clearly document all investigation results and maintain accurate and up-to-date records throughout the investigation lifecycle.
- Communicate Results: Share investigation outcomes with affected departments to ensure transparency and alignment.
- Adhere to CAPA Procedures: Ensure that the investigation adheres to the CAPA procedure, including all data entry requirements.
- Collaborate on Action and Effectiveness Plans: Work closely with the Action Owner/CAPA Owner to develop and document the Action Plan and Effectiveness Plan, including acceptance criteria and timelines.
Preferred Qualifications:
- Experience in CGT therapy or viral vector environments.
- Proficiency with TrackWise or other Quality Management Systems (QMS).
Contract Details:
- Duration: 5 months (With potential to extend)
- Please note that we can’t provide H1B sponsorship for this role
