Team Member Quality Control
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Job Location:
Monthly Salary:
Posted on:
07-11-2025
Vacancies:
1 Vacancy
Job Summary
- To ensure timely and thorough investigation of quality-related events such as deviations OOS and OOT results in compliance with regulatory standards and internal SOPs thereby maintaining product quality and patient safety.
- Deviation Handling:
- Initiate and lead investigations for laboratory and manufacturing deviations.
- Identify root causes using tools like 5 Whys Fishbone or CAPA analysis.
- Collaborate with cross-functional teams to implement corrective and preventive actions (CAPA).
- OOS Investigations:
- Conduct Phase I and Phase II investigations for OOS results.
- Review analytical data equipment logs and analyst performance.
- Coordinate retesting and reanalysis as per SOPs.
- Document findings and ensure regulatory compliance (e.g. MHRA FDA).
- OOT Investigations:
- Monitor data trends and identify atypical results.
- Investigate potential causes for OOT results and assess batch impact.
- Recommend actions to prevent recurrence.
- Documentation & Reporting:
- Prepare detailed investigation reports with evidence and conclusions.
- Maintain records in compliance with Good Documentation Practices (GDP).
- Present findings during audits and regulatory inspections.
- Compliance & Training:
- Ensure investigations align with cGMP ICH and regulatory expectations.
- Train QC analysts on investigation procedures and data integrity.
Qualifications :
to 10 years
Remote Work :
No
Employment Type :
Full-time
Key Skills
- Invoicing
- Flight Operations
- Asset
- Geography
- Jboss
- Accident Investigation
About Company
Dr. Reddys Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Cant Wa ... View more
