Senior Executive R&D Quality CMC QA

Job Title

Sr.Executive - R&D Quality CMC QA_Biotech

Business Unit

Global Quality & Compliance

Job Grade

G11B

Location :

Baroda

At Sun Pharma, we commit to helping you Create your own sunshine— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine

As you enter the Sun Pharma world, you'll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each other's journeys.

Position Summary

To provide independent quality review and oversight of CMC development and technology transfer activities, ensuring that development data, processes, and documentation are compliant, scientifically robust, and fit for technology transfer, regulatory submissions and commercial manufacturing readiness .

Key Responsibilities

• Provide quality oversight for Chemistry, Manufacturing & Controls (CMC) activities within Biotech R&D to ensure compliance with global internal quality standards and regulatory requirements.
• Review and approve CMC development documents, including Product Development Reports, Process Development Reports, Product Quality Risk Assessments, process characterization studies, control strategies, specifications, and regulatory supporting documents.
• Conduct independent quality review of upstream and downstream process development data to ensure scientific integrity, completeness, traceability, and compliance with applicable quality requirements.
• Support technology transfer process by performing quality review and approval of technology transfer protocols, reports, batch records, comparability assessments, and associated technical documentation.
• Ensure data generated during development, scale-up, engineering and submission batches are accurate, complete, and compliant with internal procedures and regulatory expectations.
• Review laboratory notebooks, analytical data packages, development reports, batch manufacturing records, and supporting documentation to verify data integrity and documentation compliance.
• Collaborate with cross functional team to facilitate successful technology transfer and timely resolution of quality-related issues.
• Verify that CMC documents intended for regulatory submissions are scientifically sound, complete, accurate, and inspection-ready.
• Drive implementation and continuous improvement of quality systems, including SOP management, protocol/report lifecycle management, risk management, change control, and stage-gate review processes.
• Ensure development laboratories operate in compliance with internal quality standards, Good Documentation Practices (GDP), data integrity principles, and applicable regulatory expectations.
  
  

Travel Estimate

Job Requirements

Educational Qualification

• Masters in Biotechnology (M. Tech / MSC) with 8-10 years of experience in biotech development / production / quality assurance
• Good understanding of biologics development, upstream and downstream processing, analytical development, and product lifecycle management.
• Knowledge of global regulatory requirements and guidelines including ICH, GMP, Data Integrity, Quality Risk Management, and regulatory submission requirements for biologics.
• Demonstrated ability to work effectively with cross-functional teams including Process Development, Analytical Development, Manufacturing, Regulatory Affairs, and Quality.
• Shall be well versed with various biotech regulations
• Shall be having good interpersonal communication and coordination amongst various functions
• Experience of working in quality assurance function is essential
  
  

Experience

Tenure : 8 to 10 Yrs

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let's create a brighter future together!

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).