Accountable for investigation of quality issues related to Laboratory investigations. Responsible for deviation investigation and out-of-specification and atypical result investigation. Reviews protocols, analytical results and/ or documents associated with investigations.
Responsibilities:
- Conducting laboratory investigations (LIR/ RAAC/ Incident and QAR) through eQMS.
- Initiation of Corrective and Preventive actions related to LIR/ RAAC/ QAR.
- On time submissions of LIR/ RAAC/ Incident and QAR for closure.
- Preparing Annual Trend for Laboratory Investigations.
- Ensuring the accuracy of the Analytical data prior to closure of investigations.
- Coordinate with the CFTs for closure of investigations.
- Tracking and on time closure of action items.
Use Your Power for Purpose
Every day, our unwavering commitment to quality ensures the delivery of protected and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance,
or research analysis, your contributions have a direct impact on patient care. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver meets the highest standards of safety and efficacy.
- Serve on cross-functional teams, conduct safety inspections, participate in investigations, recommend corrective actions, and train junior colleagues.
Here Is What You Need (Minimum Requirements)
- M.Sc in Microbiology or associate degree with minimum 8+ years of experience with relevant experience
- Strong technical skills in method validation and testing
- Experience in microbiological testings of pharmaceutical industry
- Deep understanding of pharmaceutical manufacturing, packaging, and quality assurance operations
- Detail-oriented with robust knowledge of quality systems
- Familiarity with research unit clin