Lead - Analytical Quality Assurance - Biosimilar

Job Description

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.

Key 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.

Qualifications

• 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.

Additional Information

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 robust portfolio of biosimilar products across key therapeutic areas, covering ~US$80+ Bn in innovator sales – future business pipeline covers a variety of product classes and therapy areas, and new modalities. Fully integrated organization with over two decades of experience in developing, manufacturing and commercializing multiple biosimilar products.
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.
The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself.

Our Work Culture
Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic.
For more details, please visit our career website at https://careers.drreddys.com/#!/