Novartis
QA Expert, ESO Large Molecules
This job is now closed
Job Description
- Req#: 381202BR
QA Expert, ESO Large Molecule
Location – Hyderabad #LI Hybrid
About the Role:
The position ensures all aspects of manufacturing, testing, release and distribution for key biologics and/or sterile pharmaceutical products at strategic external supplier sites comply with international standards of current Good Manufacturing Practice (cGMP), regulatory requirements, the Novartis Group Quality Manual, and the applicable Quality Agreements.
Key Responsibilities:
• Provide Leadership & manage Quality Assurance Managers in all quality related matters and to ensure that all aspects of the operational business comply with cGMP (Current Good manufacturing Practices) legal and regulatory requirements and the Novartis Quality Manual & Policies.
• Ensure that all products manufactured by site/External Supplier in addition to the imported products for local site are released to the market according to Novartis Quality Standards.
• Oversight of Quality Operations across site. Inbound QA Oversight. Outbound QA Oversight. MBR review and approval. Product release. QA for Quality Control and AS and T. QA Operational Excellence. Initiate and drive local hiring process. Line responsibility and daily walkthrough.
• Lead OpEx Projects. Investigation of Deviation, OOx, Complaints. Define and implement CAPAs. Support transfer Projects & validation studies. Track team metrics and ensure KQI /KPI meet requirements. Review and approve text and design. HSE incidents reporting and action follow up.
• New equipment commissioning Support (OQ, PQ). Define improvement areas in process and products. Resource and capacity (people and equipment) planning and workload management.
• Performance and leadership Support to specialist team. Ensure availability of equipment, chemicals and consumables, AS appropriate. SOP review and revision. Perform local training and monitor training status.
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt. Distribution of marketing samples (where applicable)About the company
At Novartis, we are reimagining medicine to improve and extend people’s lives. We are working hard to produce breakthroughs and address unmet needs for patients with devastating diseases, including genetic disorders and certain deadly cancers. Learn mo...
Notice
Talentify is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Talentify provides reasonable accommodations to qualified applicants with disabilities, including disabled veterans. Request assistance at accessibility@talentify.io or 407-000-0000.
Federal law requires every new hire to complete Form I-9 and present proof of identity and U.S. work eligibility.
An Automated Employment Decision Tool (AEDT) will score your job-related skills and responses. Bias-audit & data-use details: www.talentify.io/bias-audit-report. NYC applicants may request an alternative process or accommodation at aedt@talentify.io or 407-000-0000.