Team Member - SIT

Job Description

Job SummaryAs a member of the SIT Team, your role will involve overseeing the investigation of level 2 and 3 incidents within the pharmaceutical industry. You will collaborate closely with Cross-Functional Team (CFT) members to identify root causes and implement corrective and preventive actions. Your responsibilities will include active participation in investigating Out of Specification (OOS) cases, ensuring accurate classification in the SAP incident log, and providing support during regulatory inspections.Roles & ResponsibilitiesYour primary responsibility will be to lead the investigation of level 2 and 3 incidents, working in coordination with CFT members to determine root causes, corrective actions (CA), preventive actions (PA), and preparing detailed reports.Additionally, you will actively participate in investigating valid OOS cases and other relevant incidents, collaborating with CFT members to identify root causes, CA, PA, and report writing.You will also be tasked with reviewing level 1B incidents, offering constructive feedback for improvement, periodically assessing the trending of level 1A incidents, highlighting or escalating key observations, regularly reviewing the SAP incident log for accurate classification, and utilizing the Rubrics template for creating investigation reports.Furthermore, you will provide necessary support to the site in preparation for or during regulatory inspections related to investigations.QualificationsYou should hold a Bachelors or Masters degree in a relevant scientific field, such as Chemistry, Biochemistry, Pharmacy, or a related discipline. Additionally, you must have a minimum of 7 to 10 years of experience in the pharmaceutical or related industry, focusing on investigations and quality assurance.Skills & AttributesTechnical Skills- Possess in-depth knowledge and experience in overseeing investigations, including familiarity with root cause analysis, corrective actions (CA), and preventive actions (PA).- Demonstrate expertise in investigating valid OOS and other relevant cases.- Have familiarity with reviewing the SAP incident log and the ability to classify data accurately.- Be capable of crafting comprehensive investigation reports.- Experience in providing necessary support for regulatory inspections related to investigations.- Knowledge of regulatory requirements concerning incident investigations.Behavioural Skills- Ability to collaborate closely with CFT members.- Possess an analytical mindset for identifying root causes and developing effective solutions.- Strong problem-solving skills and attention to detail when reviewing incidents, reports, and trending data, and implementing corrective actions.- Effective communication skills for report writing and escalating key observations.- Commitment to ensuring compliance with regulatory requirements in investigations.- Ability to offer necessary support to the site in preparation for or during regulatory inspections.,

Keyskills :
Root Cause AnalysisCorrective ActionsPreventive ActionsChemistryBiochemistryPharmacyQuality AssuranceOut of Specification OOS CasesSAP Incident Log