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Team Member - Quality Control at Dr Reddy's Laboratories Limited
Hyderabad, Telangana, India -
Full Time

Start Date

Immediate

Expiry Date

04 Feb, 26

Salary

0.0

Posted On

06 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Quality Control, Deviation Handling, Root Cause Analysis, CAPA, OOS Investigations, Analytical Data Review, Regulatory Compliance, Documentation, Good Documentation Practices, Training, cGMP, ICH, Data Integrity, Cross-Functional Collaboration, Trend Monitoring, Batch Impact Assessment

Industry

Pharmaceutical Manufacturing

Description
Job Description 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 M.SC/B.Pharma 3 to 10 years
Responsibilities
The role involves leading investigations into quality-related events to ensure compliance with regulatory standards. This includes handling deviations, conducting OOS and OOT investigations, and preparing detailed reports.