Job Title: Team Lead - Quality Assurance (AQA)
Department: Quality Assurance
Company: Dr. Reddy’s Laboratories Ltd.
Location: Pydibimavaram, GMO
Job Summary:
Dr. Reddy’s Laboratories is seeking a Team Lead for the Quality Assurance (AQA) department. The role involves ensuring compliance with corporate policies, planning and executing analytical quality assurance activities, reviewing and releasing batches, and overseeing various quality assurance and validation processes.
Responsibilities:
Compliance with Corporate Policies: Ensure adherence to corporate policies (Quality, Safety, COBE, etc.).
Analytical Quality Assurance: Plan and execute activities related to analytical quality assurance.
Batch Review and Release: Review and release exhibit and commercial batches according to agreed timelines.
cGMP Compliance: Monitor and review cGMP compliance and adherence to norms.
Protocol and Report Approval: Review and approve protocols and reports related to stability studies, hold time studies, cleaning validation, method validation, method transfers, and more.
Validation and Trend Data: Approve validation protocols, reports, and trend data related to stability, water trends, and environmental monitoring.
Risk Assessment and Change Controls: Evaluate and approve risk assessments and change controls.
Investigations and CAPA: Review and approve investigations, corrective actions, and preventive actions related to incidents, OOTs, and OOSs.
Specifications and Procedures: Approve specifications, standard test procedures, and verify SOPs as applicable.
Audit Participation: Participate in both internal and external audits.
Training: Provide training to Quality Assurance personnel and new recruits.
Management Reporting: Prepare and present periodic trends and notifications data to senior management.
Team Development: Lead and develop a cohesive team to ensure capability and delivery.
Continuous Improvement: Support and participate in continuous improvement projects.
Safety, Health, and Environmental Practices: Follow safety, health, and environmental procedures and practices.
Other Duties: Carry out additional activities as assigned by upward reporting staff.
Qualifications:
Educational Qualification: M.Sc/M.Pharm in a related field.
Additional Information:
About the Department: Global Manufacturing Organisation (GMO)
Dr. Reddy’s operates 19 state-of-the-art manufacturing plants and is recognized as a leader in pharmaceutical manufacturing with a focus on quality and operational excellence.
Benefits Offered:
Career growth and professional development through personalized learning programs.
Industry-standard benefits, including medical and life coverage, family support, and relocation assistance.
Our Work Culture:
At Dr. Reddy’s, we are driven by our credo, Good Health Can’t Wait. Our culture emphasizes innovation, teamwork, and empathy, with a focus on making a meaningful impact on global healthcare.
To learn more, visit:
Dr. Reddy’s Careers
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