Website Novartis
About Novartis
Novartis stands out as a leading company with one of the most promising and exciting product pipelines in the pharmaceutical industry today. Their pipeline is filled with innovative medicines that have the potential to transform healthcare and improve patients’ lives. This remarkable progress is a result of the combined efforts of a diverse and highly talented workforce.
Senior Executive (NCQ) – Quality Assurance in Pharma Industry
Job Description:
• Ensure implementation, maintenance, and upgrading of the local Quality System and Standard Operating Procedures to drive compliance with cGXP and Pharmacovigilance regulations.
• Actively involved in quality governance and planning through the establishment of the annual Quality Plan, Key Quality Indicators, and Quality Risk Assessments.
Key Responsibilities:
• Establish and maintain a local Quality System and Standard Operating Procedures for all GxP related activities, ensuring compliance with cGMP through training and internal audits.
• Oversee drug product release in accordance with registered specifications and local regulations (Batch Release).
• Ensure compliance of pharmaceutical handling and distribution with Novartis Pharma Quality Manual, cGMP, and regulatory requirements.
• Supervise and coordinate activities of CPO Vendors, ensuring compliance with Novartis Standards.
• Resolve Critical Quality Issues according to Quality Assurance Agreement and Novartis Pharma Quality Manual.
• Manage change requests from External Suppliers/Vendors and Novartis CPO.
• Prepare Quality trends and drive continuous improvement for processes and product quality performance.
• Provide quality input in Compliance/Technical meetings with CPO Vendors.
• Support internal functions (BD&L, CRO, etc.) in product evaluation based on Novartis Pharma Quality Manual and standards.
Candidate Profile:
• B.Sc., B.Pharm with Postgraduate Diploma (added advantage).
• Fluent in local language, English, and Hindi (speaking/writing).
• 4+ years of experience in QA/QC, with knowledge of cGMP and regulatory compliance in relevant operations. • Proficient in communicating with vendors and internal customers.
• Strong interpersonal skills, operational excellence, and continuous learning.
Additional Information:
• Experience: 4+ years
• Qualification: B.Sc., B.Pharm with Postgraduate Diploma (added advantage)
• Location: Mumbai
• Industry Type: Pharma/Healthcare/Clinical research
• Functional Area: Quality
• End Date: 31st August 2023
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