Lead - Analytical Quality Assurance - Biosimilar

Responsibilities

• Oversee testing and release activities for Raw Materials, Packaging Materials, In-process, and Finished Products in compliance with cGMP and regulatory requirements.
• Review and approve: Stability protocols and reports
• Standard Test Procedures (STPs) and product specifications
• Analytical method validation and transfer protocols/reports
• Internal Reference Standard qualification and re-qualification
• LIMS master data , ensuring alignment with approved test methods
• Allocate daily testing priorities based on business needs and resource availability.
• Provide technical guidance to QC analysts on analytical techniques and troubleshooting.
• Participate in cross-functional technical discussions to resolve analytical and quality issues.
• Ensure timely closure of QMS elements including Deviations, Change Controls, CAPAs, OOS, and OOT.
• Conduct audit trail reviews and ensure compliance with data integrity standards.
• Support batch analysis report reviews and coordinate with QA for timely batch release.
• Perform GEMBA walks to monitor laboratory practices and ensure GLP compliance .
• Collaborate with the Site Investigation Team and other departments to conduct effective root cause analysis and implement robust CAPAs.
• Bachelor's/Master's degree in Pharmaceutical Sciences, Chemistry, or related field
• Minimum 12+ years of experience in Quality Control within the pharmaceutical industry
• Strong knowledge of ICH guidelines, cGMP, GLP, and regulatory requirements
• Experience with LIMS , analytical method validation , and data integrity practices
• Proven leadership and team management skills
• Excellent communication and cross-functional collaboration abilities
• Ability to succeed in a team-oriented environment under very dynamic conditions.
• Excellent communication, technical writing, organizational skills and use of Microsoft office products.
• About the Department
• Biologics
• Currently operates in the Global Biosimilars business - a segment that is poised for attractive and sustained growth over the next 10-15-year time horizon.
• With a Product Development engine that has end-to-end capabilities - in-house clone development, upstream and downstream process development, bioanalytical development and proprietary formulation.
• Supported by a Clinical and Regulatory team with experience in executing complex biosimilar programs with innovative global trial designs.
• We have a proven experience in commercial-scale manufacturing across a variety of technology platforms with global quality standards and a highly competitive cost structure
• Rich experience of commercializing high-quality biosimilars in multiple markets with over 900,000 patients having benefited from our products till date.
• Benefits Offered
• At Dr. Reddy's we actively help to catalyse your career growth and professional development through personalised learning programs.
• Our Work Culture
• For more details, please visit our career website at https://careers.drreddys.com/#!/

Benefits

Additional Information

The Lead - Analytical Quality Assurance is responsible for providing strategic and operational leadership to ensure the quality and compliance of all laboratory testing activities. This role oversees the review and approval of analytical documentation, ensures audit readiness, and supports cross-functional collaboration to maintain high standards of product quality and regulatory compliance.

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