13 Nov
|
SunPharma
|
India
Job Title: Senior Manager
Business Unit: Sun Global Operations
Job Grade: G9
Location: Sun House
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:
- Plan, conduct, and lead internal corporate quality audits across Sun manufacturing sites.
- Audit analytical laboratories, stability and microbiology including R&D; Labs. (QC SME)
- Review laboratory controls compliance with USP, EP, IP, and other regulatory expectations.
- Assess laboratory investigations including OOS, OOT, atypical results, and invalidation practices.
- Evaluate data integrity controls within laboratory systems.
- Review method validation, transfer, verification, and lifecycle management processes.
- Conduct follow-up audits to verify CAPA effectiveness.
- Evaluate computerized systems used in QC laboratories.
- Review inspection observations and assess compliance risks.
- Support sites during USFDA, MHRA, Health Canada, TGA, ANVISA and other inspections.
- Prepare comprehensive audit reports and assess CAPA provided for correctness and completeness.
- Evaluate audit trail reviews and electronic records management.
- Track audit observations and CAPA closure timelines.
- Develop corporate quality metrics and compliance dashboards.
Travel Estimate:
- Need base
Job RequirementsEducational Qualification: Master of Science
Experience: Tenure: Min 18 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 skilled 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 has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications
📌 Senior Manager - Corporate Quality Audit (India)
🏢 SunPharma
📍 India