Section Head QA – OSD

Role Purpose

To lead InProcess Quality Assurance activities for OSD formulation manufacturing ensuring cGMP compliance data integrity inspection readiness and RightFirstTime execution in line with Quality Management System and global regulatory expectations.

Key Responsibilities

IPQA Manufacturing & Packaging

• Ensure realtime QA oversight during dispensing granulation blending compression coating ampoule and packing operations.
• Review and ensure compliance of BMRs/BPRs inprocess checks and critical process parameters.
• Manage line clearance batch initiation and batch closure activities.
• Ensure adherence to ALCOA principles and data integrity requirements.
• Support process validation cleaning validation and technology transfer batches.

Investigations & Quality Managment Systems

• Lead and support deviations OOS/OOT incidents and market complaints (if applicable).
• Drive root cause analysis (RCA) and ensure robust CAPA implementation and effectiveness checks.
• Participate in change control risk assessment and continual improvement initiatives.

AQA Analytical Quality Assurance

• Review and approve analytical data related to raw materials inprocess finished products stability and cleaning samples.
• Ensure compliance with analytical SOPs test methods specifications and pharmacopeial requirements.
• Review and support investigations related to OOS OOT atypical results laboratory incidents and method-related deviations.
• Ensure data integrity compliance in QC laboratories including audit trails CDS LIMS and manual records.
• Review method validation method transfer and analytical change control documents.
• Participate in stability program review trend analysis and analytical risk assessments.

Qualifications :

Educational Qualification

• / / (Chemistry or relevant discipline)

Experience

• 15 years of experience in QA OSD formulation manufacturing
• Minimum 23 years in a senior executive / team leadership role
• Exposure to AQA OOT and OOS Investigation

Additional Information :

Benefits Offered

At Dr. Reddys we actively help to catalyse your career growth and professional development through personalised learning programs.

The benefits you will enjoy at Dr. Reddys 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. Reddys why they come to work every day and theyll say because Good Health Cant 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 were 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 Work :

No

Employment Type :

Full-time