Dr. Reddy’s Laboratories Exciting Career Opportunity -Send Resume And Apply Online

Job Summary
We are seeking an individual for the Quality Assurance team, responsible for overseeing various quality assurance activities to ensure compliance with regulatory requirements and maintain product quality. Your responsibilities will include managing change notifications, conducting investigations, handling market complaints, coordinating audits, and supporting regulatory filings.

Roles & Responsibilities

• Review of Technology transfer documents, Review of process and cleaning trial and validation documents, nitrosamine impurity assessments, CPV reports, batch production records and cleaning records etc.
• Reviewing and approving Quality Risk Management processes to identify, assess, and mitigate risks to product quality and patient safety.
• Performing SAP activities and updating Bills of Materials (BOM) and recipes accurately to reflect product specifications and changes.
• Monitoring plant activities related to trial and Validations.
• Supporting marketing queries and DMF filings.
• Ensuring compliance with good manufacturing practice, GxP, and other regulatory requirements through self-training and adherence to established procedures.

Educational qualification: M.Sc in Chemistry.

Minimum work experience: 3 to 12 years of experience in pharmaceutical manufacturing or a similar role

Skills & attributes:

Technical Skills

• Knowledge of process and cleaning validation activities, sampling and relevant standards.
• Proficiency in performing line clearance, material verification, start-up checks, and in-process checks following batch manufacturing and packing records.
• Experience in timely sampling and testing of in-process, reserve, and finished samples, as well as stability samples and environmental monitoring.
• Skilled in reviewing batch manufacturing and batch packing records, ensuring accuracy and certification after execution.

Behavioural Skills

• Attention to detail in performing line clearance, verification, and record reviews.
• Skilled in time management and coordination for sampling, testing, and execution of batch manufacturing and packing activities.
• Communicates effectively with team members and stakeholders regarding batch-related activities and compliance.
• Applies problem-solving skills in addressing issues related to line clearance, sampling, and record certification.
• Demonstrates a focus on maintaining high-quality standards and adhering to regulatory compliances in manufacturing processes.

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