Senior Manager Quality Compliance OSD

Job Title:

Senior Manager Quality Compliance OSD

Business Unit:

Global Quality & Compliance

Job Grade

G9B

Location :

Halol-2

 

 

 

 

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.”

 

Key responsibilities:

• Accountable for ensuring OSD quality compliance activities at the site.
• Managed the Third-party consultant at site
•  Oversee regulatory audits, including preparation of responses and closure of commitments.
• Manage corporate audits along with response submission and timely closure of commitments.
• Handle customer audits, ensuring effective responses and completion of all commitments.
• Lead and coordinate OSD remediation activities at the site.
• Drive and manage global CAPA initiatives.
• Oversee vendor qualification management for sterile and OSD products, including APIs, excipients, and packaging materials.
• Lead site internal inspections, ensuring proper management and timely escalation of issues.
• Manage contract service providers for both sterile and OSD functions.
• Handle nitrosamine assessment activities, including timely escalation of concerns.
• Support and manage Management Review Board activities related to inspections.
• Lead critical and data integrity investigations, and review CAPA effectiveness.
• Conduct gap assessments related to guidelines, FDA 483 observations, and other Sun network site observations.
• Review the periodic quality system and escalation on timely manner.
• Review and approve SOPs for the compliance department.

Travel Estimate

NA

Job Requirements

Educational Qualification

B. Pharmacy / M. Pharmacy

Experience

Tenure:  15 years

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).