Dr Reddy's Laboratories Limited
pharmaceutical
TeamMember–SIT(Engineering)
“Team Member – SIT (Engineering) at Dr Reddy's Laboratories Limited. Skills: Investigation of level 2 and 3 incidents, Root cause analysis, Corrective and preventive actions, Regulatory compliance. Overseeing the investigation of level 2 and 3 incidents. Collaborating with Cross-Functional Team (CFT) members to identify root causes, corrective actions (CA), and preventive actions (PA)”
Industry & Context.
Analytical mind set for identifying root causes and developing effective solutions; Problem-solving skills and attention to detail in reviewing incidents, reports, and trending data and implementing corrective actions
What They're Looking For.
Must Have
Bachelor's or Master's degree in a relevant scientific field, such as Chemistry, Biochemistry, Pharmacy, or related discipline, 7 to 10 years of experience in a pharmaceutical or related industry with a focus on investigations and quality assurance, In-depth knowledge and experience in overseeing investigations, Familiarity with root cause analysis, corrective actions (CA), and preventive actions (PA), Expertise in investigating valid OOS and other relevant cases, Familiarity with reviewing SAP incident log and ability to perform classification of data, Ability to craft comprehensive investigation reports, Experience in providing necessary support for regulatory inspections related to investigations, Knowledge of regulatory requirements pertaining to incident investigations
Nice to Have
Cross-Functional Team (CFT) members collaboration, Analytical mind set for identifying root causes and developing effective solutions, Problem-solving skills and attention to detail in reviewing incidents, reports, and trending data and implementing corrective actions, Effective communication skills for report writing and escalation of key observations, Commitment to ensuring compliance with regulatory requirements in investigations, Ability to offer necessary support to the site in readiness for or during regulatory inspections
What You'll Do.
Overseeing the investigation of level 2 and 3 incidents
Collaborating with Cross-Functional Team (CFT) members to identify root causes
corrective actions (CA)
and preventive actions (PA)
Preparing comprehensive reports
Investigating Engineering
Utilities & Manufacturing and other relevant cases
Reviewing level 1B incidents and providing feedback
Assessing trending of level 1A incidents and highlighting key observations
Ensuring accurate classification in the SAP incident log
Utilizing the Rubrics template for investigation reports
Providing support during regulatory inspections related to investigations
How You'll Work.
Team & Collaboration
Collaborating closely with Cross-Functional Team (CFT) members to identify root causes, corrective actions (CA), and preventive actions (PA); Working closely with CFT members to determine root causes, CA, PA, and report writing
Communication Scope
Effective communication skills for report writing and escalation of key observations
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