What are the responsibilities and job description for the QLA III – Microbial Investigations position at TekOne IT Services Pvt. Ltd.?
Microbial Investigations: Lead the investigation of microbial excursions, including surfaces, viable air, non-viable air, water, bioburden, and endotoxin testing results.
Root Cause Analysis: Identify root causes for microbial out-of-limits events and initiate immediate mitigation actions.
CAPA Implementation: Define and implement effective corrective and preventive actions (CAPAs) to prevent recurrence of microbial excursions.
Cross-Functional Collaboration: Assemble cross-functional teams to conduct interviews, observe operations, and drive investigations to closure.
Regulatory Compliance: Ensure all investigations meet compliance standards, working within the TrackWise system to document and manage CAPAs.
Process Improvement: Foster collaborative relationships to continuously improve investigation processes and reduce out-of-limit generation rates.
Timely Resolution: Ensure investigations are closed in a timely manner to meet both business and regulatory compliance needs.
Regulatory Defense: Present and defend investigations during regulatory inspections, as required.
Qualifications
Education: Bachelor’s or Master’s degree in Microbiology or related scientific field.
Experience: Minimum of 5 years in Quality Operations, Microbiology Laboratory, or related areas in the pharmaceutical/medical products industry. At least 2 years of experience conducting root cause investigations.
Technical Skills:
Strong understanding of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
Knowledge of FDA quality systems regulations.
Expertise in problem-solving methodologies such as DMAIC.
Hands-on experience with the TrackWise system for CAPA and investigation management.
Skills:
Strong technical writing skills, with the ability to clearly document investigations and corrective actions.
Excellent communication and project management abilities.
Ability to interact and influence across multiple departments at various levels.
Strong analytical, troubleshooting, and investigative skills.
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