Dr.Reddys Laboratories Ltd Recruitment

Dr.Reddys Laboratories Ltd Walk-in Interview.Dr.Reddys Laboratories Ltd Notification full details below.Interested and eligible candidates can attend Interview on scheduled time and venue.

Important Details :

• Selection Process: The selection will be on the basis of Interview.
• Mode of Interview: Face to face
• Interview Rounds of Interview: HR
• Job Location: Hyderabad

Vacancy details:

• Department: DS Quality Assurance Associate
• Qualification: M.sc (Life Science)  /M Pharm
• Experience: 8-10  years of industrial experience with specific operational experience in Quality Assurance and Manufacturing (Biosimilars)
  

Job Description : Greeting from Dr.Reddys Laboratories Ltd..!!!!

Job Summary

We are seeking an individual to verify compliance for activities in the respective counter function regularly. This role involves reviewing real-time investigations, ensuring smooth batch manufacturing and testing activities, and evaluating practices against defined standards, to ensure consistent product quality and operational compliance within the regulatory framework and global standards.

Key Responsibilities – Drug Substance Quality Assurance (DS-QA)

Batch Production Record (BPR) Review & Documentation

Review executed Drug Substance (DS) BPRs and associated documents for all products.

Ensure timely deposition of reviewed documents to the DCQA.

Document Review & Approval

Review and approve Master Formula Records (MFRs), BPRs, Bill of Materials (BOMs), Standard Operating Procedures (SOPs), Product Quality Reviews (PQRs), action plans, and other relevant documents for both existing and new products.

Protocol & Report Evaluation

Review and approve various protocols and reports, including technology transfer documents related to DS manufacturing processes.

Quality Systems Oversight

Initiate, review, and approve investigations, discrepancies, Corrective and Preventive Actions (CAPAs), Change Controls, and Quality Risk Management (QRM) activities.

Audit Support

Provide support during internal and external audits.

Ensure timely closure of audit observations and implementation of corrective actions.

GMP Compliance Monitoring

Monitor shop floor activities to ensure compliance with Good Manufacturing Practices (GMP).

Conduct routine and non-routine spot checks.

Line Clearance & Critical Activity Oversight

Provide line clearance for product changeovers and oversee critical activities as per SOPs across DS facilities.

SOP & Document Management

Create, revise, and review SOPs, forms, and other DS-QA-related documents as required.

GMP Record Verification

Perform periodic verification of GMP records in alignment with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available).

Qualification & Validation Review

Review and approve process and cleaning qualification/validation protocols and reports.

Audit Trail Review

Review system and process audit trails as per the defined schedule.

Perform audit trail reviews for equipment.

Issuance of Cell Banks for  Manufacturing Operations

Issue Work Cell Banks (WCB) and Master Cell Banks (MCB) as per requirements.

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