769 million lives were touched by Novartis medicines in 2020, 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!
- Post : Executive Quality Assurance
- Qualification: M. Pharm/B. Pharm. from reputed institute with more than 5 years of Quality Assurance experience in a pharmaceutical company involved in qualification of production equipment’s and utility systems.
- Experienced: 05 years
- Location: Mumbai
Your key responsibilities:
Your responsibilities include, but not limited to:
• Equipment/System/Utility Qualification (URS, DQ. IQ, OPQ etc.) and to ensure the compliance of qualification activities and projects at site including Periodic requalification requirements. RMS (Room Monitoring System) and BMS (Building Monitoring System) qualification and to ensure routine compliance.
• Calibration and Maintenance of Engineering equipment and Utility system to ensure compliance. Expertise in the Computerized system (as per GAMP guideline) qualification of equipment.
• Knowledge of utility of purified water and HVAC system and its compliance as per current guidelines. Continuous oversight and governance on engineering activities to ensure the compliance and maintain the quality KPIs.
• Monitoring / task completion for Room management System (RMS), Building management system (BMS) Purified Water System, Compressed air and Nitrogen System, Pretreatment system, HVAC system monitoring, Filter management, Other Utility i.e. Hot water, Chilled water Diesel Generator and UPS etc., Calibration activity, Unplanned Maintenance and Planned and unplanned maintenance activities etc. Governance of Service floor and Technical Area with respect to cleaning and GMP compliance.
• Prepare, review of SOPs to ensure the implementation of SOP within the state of compliance and ensure the SOPs are inline with guideline requirements. Ensure the compliance of engineering activities as per defined SOPs or GOPs.
• Knowledge of investigation initiated during deviation/OOS or market complaints related engineering activities or during the manufacturing activities. GMP & abiding and ensuring compliance to the Health, Safety & Environment policy.
• Ensure integrity of data and good document practices at workplace. Ensure compliance with Pharmacopoeia/Group Requirements /local and international authorities. To provide support in customer/authority inspections. Ensure safe custody and efficient handling of company documents and materials.
Commitment to Diversity & Inclusion:
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 more than 5 years of Quality Assurance experience in a pharmaceutical company involved in qualification of production equipment’s and utility systems.
• Hands on experience on equipment qualification process & periodic review of equipment qualification.
• Experience in equipment calibration/maintenance, documentation review.
• Experience working in Tablet & Capsule or solid oral dosage manufacturing.
• Knowledge of Microsoft application i.e. word, excel and PPT.
• Good communication skill to discuss with stake holder of site to ensure the activity and compliance on time.
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!
Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to diversityandincl.india@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Join our Novartis 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
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