Senior Executive RandD Quality CMC QA

SUN PHARMA; Vadodara; On-site; INR 1,800,000 - 2,500,000; Full time

Job summary

Sun Pharma seeks a Sr. Executive - R&D Quality CMC QA_Biotech to provide independent quality review and oversight of CMC development and technology transfer activities.

You will ensure that data, processes, and documentation are compliant, robust, and ready for regulatory submission and commercial readiness. You will review development documents, drive data integrity, and support technology transfer while collaborating with Process Development, Analytical Development, Manufacturing and

Qualifications

• Masters in Biotechnology with 8–10 years of biotech QA/CMC experience.
• Strong understanding of ICH, GMP, data integrity and regulatory submissions.
• Cross-functional collaboration across PD, Analytical, Manufacturing and Regulatory.

Responsibilities

• Provide quality oversight for CMC activities in Biotech R&D for regulatory readiness.
• Review and approve CMC development documents and regulatory supports.
• Conduct independent quality reviews of development data for integrity and compliance.
• Support technology transfer through QA review of protocols, reports and batch records.
• Ensure data generated during development and submission batches is accurate and compliant.
• Collaborate with cross-functional teams to resolve quality issues promptly.
• Drive continuous improvement of quality systems and GDP practices.

Skills

Quality Assurance

CMC

Biotech Knowledge

Regulatory Compliance

Data Integrity

Documentation Review

Technology Transfer

Education

Masters in Biotechnology

Job description

Job Description:

Sr.Executive - R&D Quality CMC QA_Biotech

Global Quality & Compliance

G11B

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.

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).