What are the responsibilities and job description for the Quality Assurance Validation II, position at TekOne IT Services Pvt. Ltd.?
Key Responsibilities
- Microbial Investigation SME: Lead and manage microbial investigations related to surfaces, viable air, non-viable air, water, bioburden, and endotoxin testing results.
- CAPA Management: Utilize TrackWise to manage investigation and CAPA documentation, ensuring that all incidents are tracked, documented, and resolved efficiently.
- Root Cause Analysis: Determine the scope, product impact, root cause, and corrective/preventive actions for microbial excursions.
- Cross-Functional Leadership: Assemble and lead cross-functional teams, conduct interviews, and observe operations to complete comprehensive investigations.
- Immediate Mitigation: Identify potential root causes and take immediate actions to mitigate risks and resolve issues.
- Regulatory Compliance: Prepare, present, and defend investigations during regulatory inspections as required, ensuring compliance with industry standards.
- Process Improvement: Lead CAPA projects focused on process improvements, driving investigations to timely and effective closure.
- Technical Writing: Create and maintain clear, concise, and detailed technical reports and documentation throughout the investigation process.
- Education: Bachelor’s or Master’s degree in Microbiology or a related scientific field.
- Experience:
- Minimum 2 years of experience conducting root cause investigations in the pharmaceutical/medical products industry.
- At least 5 years of experience in Quality Operations, Microbiology Laboratory, or related quality functions.
- Skills and Expertise:
- In-depth knowledge of microbial testing and contamination control.
- Strong experience with TrackWise for CAPA and investigation management.
- Ability to identify root causes, determine product impact, and implement corrective/preventive actions.
- Excellent leadership skills with the ability to collaborate with cross-functional teams.
- Exceptional technical writing skills for preparing detailed reports and defending investigations during regulatory audits.
