Manager - CMO

Job Title:

Manager CMO

Business Unit:

Global Quality & Compliance

Job Grade

G10 -Manager-1 / G9B (SM-2)

Location :

Mumbai

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.

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 :

Quality Oversight”  for USA Markets.

Key responsibilities:

1. Participate in the initial evaluation of Contract Manufacturing Organizations (CMOs).

2. Should possess sound knowledge of pharmaceutical manufacturing process (Non-sterile & Sterile formulations) & quality assurance regulations and auditing technique.

3. Should have experience in managing manufacturing operations at External contract manufacturing sites.
4. 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.
5. Ensure that the CMO operations are in compliance with global regulatory standards (FDA, EMA, WHO, ICH) and SUN internal quality systems.
6. Review and maintain quality agreements with CMOs to ensure compliance and quality standards.
7. Review the batch records, validation protocols, and analytical reports for sterile injectable formulation for USA Market.
8. Support for the project management team during the execution of exhibit/scale-up batches at the CMO site.
9. Collaborate with cross-functional teams including Regulatory Affairs, Manufacturing, and Supply Chain to ensure product quality and compliance.
10. Drive continuous improvement initiatives and inspection readiness at CMOs
11. Minimum 13 years of pharmaceutical QA experience, with strong exposure to injectable manufacturing operations for Regulated markets.

Travel Estimate

Job Requirements

Educational Qualification

M.Sc / B.Pharm / M.Pharm

Experience

Tenure:  14+ years of Industry experience and working knowledge in regulatory environments. Experience in handling  quality managements systems or Production Experience

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!

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