Dr. Reddy’s Laboratories is committed to maintaining a workplace that fosters diversity and inclusion, being an equal opportunity employer. The organization values talent across all backgrounds, irrespective of race, color, religion, nationality, gender, age, disability status, sexual orientation, or other protected characteristics. Dr. Reddy’s prides itself on recognizing and nurturing diverse talent while upholding high standards of merit and inclusivity.
Job Description: Quality Assurance Specialist
Job Summary
Dr. Reddy’s Laboratories is seeking a dedicated and detail-oriented individual for their Quality Assurance team. The role involves ensuring line clearance, material verification, and conducting in-process checks as per batch manufacturing and packing records. The specialist will also be responsible for timely sampling/testing, coordination during cleaning validation processes, and upholding compliance with technology transfer and exhibit batches. Additionally, the review and certification of batch records post-execution are crucial aspects of this position.
Key Responsibilities
- Line Clearance & Material Verification: Execute line clearance, verify materials, conduct start-up checks, and perform in-process checks as per batch manufacturing and packing records.
- Sampling & Testing: Carry out timely sampling and testing of in-process, reserve, finished, and stability samples for Topical and OSD formulations.
- Cleaning Validation Coordination: Coordinate and perform sampling for cleaning validation activities and ensure compliance with established protocols.
- Technology Transfer Compliance: Assist in the initiation and compliance of exhibit batches during technology transfer.
- Batch Record Review: Review batch manufacturing and packing records and provide certification post-execution.
Qualifications
- Educational Requirements: Bachelor’s degree in Pharmacy, Master’s in Pharmacy, or a related field.
- Experience: 3 to 5 years in pharmaceutical manufacturing or a related quality assurance role.
Technical Skills
- Expertise in cleaning validation, sampling techniques, and adherence to standards.
- Ability to conduct line clearance, material verification, and in-process checks as per batch records.
- Proficiency in sampling and testing processes for in-process, reserve, and stability samples.
- Competency in reviewing and certifying batch manufacturing and packing records.
Behavioural Skills
- Attention to Detail: Precision in performing line clearance, verification, and record reviews.
- Time Management: Effective coordination of sampling, testing, and manufacturing/packing execution.
- Communication: Clear and effective communication with team members and stakeholders to ensure compliance.
- Problem Solving: Application of problem-solving skills to manage issues related to line clearance, sampling, and record certification.
- Quality Focus: Strong adherence to maintaining high standards of quality and regulatory compliance in manufacturing.