09 Oct
|
Sun Pharmaceutical Industries
|
Mumbai
09 Oct
Sun Pharmaceutical Industries
Mumbai
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 Requirements
Educational 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 perks and opp
📌 Senior Manager (Mumbai)
🏢 Sun Pharmaceutical Industries
📍 Mumbai