Manager - CMO Quality

Sun Pharmaceutical Industries Ltd; Gurugram District; On-site; INR 4,000,000 - 9,000,000; Full time

Job summary

Sun Pharma is seeking a Manager CMO in Gurgaon to ensure Quality and Compliance across global CMOs and regulatory requirements. This role focuses on overseeing QMS elements, change control, deviations and investigations for injectable and OSD products targeting emerging markets.

Required: 12+ years in pharmaceutical QA with experience in global regulatory environments and strong exposure to injectable and oral solid dosage operations.

Qualifications

• Experience in QA for pharmaceutical manufacturing and global regulatory environments.
• Strong exposure to injectable manufacturing and OSD operations for global markets.
• Proven ability to lead QMS elements and regulatory compliance programs.

Responsibilities

• Participate in initial evaluation of CMOs.
• Manage manufacturing operations at external sites.
• Lead and monitor QMS elements reported by CMOs (change control, deviations, incidents, OOS/OOT, investigations).
• Ensure CMO operations comply with FDA, EMA, WHO, ICH and SUN standards.
• Review quality agreements and batch records, validation protocols and analytical reports for sterile injectables and OSD products.
• Coordinate with SUN internal teams as needed.
• Oversee quality management systems to maintain compliant operations.
• Minimum 12 years of pharma QA experience with injectable and OSD manufacturing exposure.

Skills

Quality Assurance

Regulatory Compliance

GxP Knowledge

Quality Oversight

Education

M.Sc / B.Pharm / M.Pharm

Tools

QMS

Job description

Job Title:

Manager CMO

Business Unit:

Global Quality & Compliance

Job Grade

Manager

Location :

Gurgaon

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.”

Job Summary :

To ensure that SUN Pharma Quality and Compliance Standards, and applicable global regulatory authorities’ requirements are met and that all CMOs achieve, maintain and improve the adequate level of compliance, through “Quality Oversight .

Key responsibilities:

1. Participate in the initial evaluation of Contract Manufacturing Organizations (CMOs).
2. Should have experience in managing manufacturing operations at External contract manufacturing sites.
3. Lead, oversee, approve & monitor Quality Management System (QMS) elements reported by CMOs, including change control, deviations, incidents, out of Specification (OOS)/out of Trend (OOT) results, and complaint investigations targeting for injectable & OSD products manufactured for emerging markets.
4. Ensure that the CMO operations are in compliance with global regulatory standards (FDA, EMA, WHO, ICH) and SUN internal quality systems.
5. Review and maintain quality agreements with CMOs to ensure compliance and quality standards.
6. Review the batch records, validation protocols, and analytical reports for sterile injectable formulations & OSD Products manufactured for Emerging markets.
7. Coordinate and support to SUN internal teams as on when necessary.
8. Minimum 12 years of pharmaceutical QA experience, with strong exposure to injectable manufacturing and Oral solid dosage manufacturing operations for Global markets.

Travel Estimate

Job Requirements

Educational Qualification

M.Sc / B.Pharm / M.Pharm

Experience

Tenure: 12+ years of Industry experience and working Knowledge in domestic and regulatory environments. Experience in handling quality managements systems.

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).