May 04, 2022

Job Description

With 64 manufacturing sites in 26 countries, our aspiration is to become the top manufacturer of innovative and generic medicines in the industry.
Position Purpose:
Responsible for managing quality aspects within area of responsibility and to ensure that the operational business is in compliance with cGMP (Current Good Manufacturing Practices), the Quality Assurance Agreement, regulatory requirements & the Novartis Quality Manual and is conducted according to the relevant Standard Operating Procedures. Represent Operation QA and investigations during HA inspections. Highly skilled & experienced Quality professional who contributes by managing of shop floor QA and Engineering QA activities at Kalwe site (OSD).
Your key responsibilities:
Your responsibilities include, but are not limited to:
• Implementing Sandoz/Novartis group quality policies; ensure Compliance of local Regulatory/EU/US/ICH & international guideline as applicable to Kalwe site. To ensure planning and coordination of IPQA related activity in coordination with supervisor to monitor Line clearance, IPM, Document review, sampling and SFG release activity.
• Ensure and coordinate that all IPQA activities are being done as per SOP. To ensure that Production adheres to GMP standards, procedures and systems in all respects of manufacturing including storage.
• Ensure QA oversight on warehouse and Engineering activities. Support Complaints, Deviation and OOS investigation w.r.t. shop floor investigation. Review and approval of GMP documents like, QRA, investigations reports, Qualification documents etc. Ensure all time inspection readiness on shop floor and provide support in customer /Health authority inspections. To support self-inspection at site.
• To review and approve SOP's related to QA, Production, Engineering, Warehouse, and other departments. To support in execution of the validation protocol, Review and Approval of process validation protocol/ report and continued process verification protocol/ report.
• Ensure timely closure of CAPAs related to Health Authority, Global Compliance and Auditing group. Participate in intra and inter departmental meeting & discussions. Co-ordination with other departments for day-to-day activities.
• Ensure the company's adherence to the required norms of local and international authorities /group guidelines. Ensure timely notification /Management escalation & Reporting of potential quality defects that arise and may affect product on the market. Maintain confidentiality ensure safe custody and efficient handling of company documents and materials.
• Perform any other task that may be assigned for running of the company as per latest quality standard and Novartis Corporate Guidelines. Any other responsibility that may be assigned by supervisor/Manager from time to time.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

What you’ll bring to the role:
• M. Pharm/B. Pharm. from reputed institute with min 15+ yrs of exp preferably in oral solid Dosage.
• Collaborating across boundaries.
• Shop floor activities, QMS, Audit & Other GMP activities, Engineering services, Quality decision making, Knowledge of production systems, IT Applications & tools, TQM and related industry GxP standards and processes.

Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Join our Novartis Group Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

Why Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
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Novartis Technical Operations
Full Time
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Sr. Manager Quality Assurance

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