Team Lead, Quality Operations Qsc Job in Novartis
Team Lead, Quality Operations Qsc
Novartis
4+ weeks ago
- Hyderabad, Telangana
- Not Disclosed
- Full-time
- Permanent
Job Summary
Responsible for handling 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 and the Novartis Quality Manual and is conducted according to the relevant Standard Operating Procedures.
YOUR KEY RESPONSIBILITIES:
Your responsibilities include, but are not limited to:
- Ensure quality services are delivered on time and in full and in line with partner and Novartis quality Management requirements. Lead and identify potential areas where Quality Operations can add value to quality function and beyond.
- Oversight of all production and testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance -Support exception investigations -Review and approval of production, QC, and AS & T records -MBR review -Support OpEx improvement projects Qualified Person Executes batch release in compliance with registration
- Update the QSC catalogue to stay current and meets the partner/ company requirements. Ensure business case is built and vital agreements (service level, quality etc.) are in place prior to provision of the services.
- Act as single point of contact for the services delivered to sites/ functions by the respective team, including the review of feedback and timely completion of identified actions. Channels requests and calls out critical issues in line with the incident management process.
- Project manages and coordinates for a smooth knowledge transfer activities from site/ function to QSC Maintain and report functional score card as part of QSC performance.
- Drive talent agenda: Lead people process through recruitment, training, coaching and performance management to meet all operation requirements improving competitiveness and diversity. Supports a robust succession plan for the organization.
- Drive the cultural development building on collaboration, speak-up, trust, empowerment, quality and data integrity.
- Degree in Life Sciences, Pharmacy or Medicine. Advanced degree desirable. Fluency in English (oral and written); additional language(s) a plus.
- Minimum 10+ years of working experience in regulated activities and QA. Good understanding of national and international Health Authority regulations.
- Profound understanding of product development and manufacturing activities. Ability to effectively interact with and present to senior management at all levels, as well as to external audiences and inspectors.
- Clear and open in communication. Able to build effective teams. Strong negotiation and problem solving skills.
- Considerable organization awareness (e.g. inter-relationship of departments, business priorities), including substantial experience working cross-functionally and in global teams. Knowledge and understanding of cultural differences and diversity issues.
Why consider Novartis?
799 million. Thats how many lives our products touch. And while were proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more peoples lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where youre given opportunities to explore the power of digital and data. Where youre empowered to risk failure by taking smart risks, and where youre surrounded by people who share your determination to tackle the worlds toughest medical challenges.
Imagine what you could do at Novartis!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusion workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
Novartis is an equal opportunities employer and welcomes applications from all suitably qualified persons.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Job Description
POSITION PURPOSE:Responsible for handling 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 and the Novartis Quality Manual and is conducted according to the relevant Standard Operating Procedures.
YOUR KEY RESPONSIBILITIES:
Your responsibilities include, but are not limited to:
- Ensure quality services are delivered on time and in full and in line with partner and Novartis quality Management requirements. Lead and identify potential areas where Quality Operations can add value to quality function and beyond.
- Oversight of all production and testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance -Support exception investigations -Review and approval of production, QC, and AS & T records -MBR review -Support OpEx improvement projects Qualified Person Executes batch release in compliance with registration
- Update the QSC catalogue to stay current and meets the partner/ company requirements. Ensure business case is built and vital agreements (service level, quality etc.) are in place prior to provision of the services.
- Act as single point of contact for the services delivered to sites/ functions by the respective team, including the review of feedback and timely completion of identified actions. Channels requests and calls out critical issues in line with the incident management process.
- Project manages and coordinates for a smooth knowledge transfer activities from site/ function to QSC Maintain and report functional score card as part of QSC performance.
- Drive talent agenda: Lead people process through recruitment, training, coaching and performance management to meet all operation requirements improving competitiveness and diversity. Supports a robust succession plan for the organization.
- Drive the cultural development building on collaboration, speak-up, trust, empowerment, quality and data integrity.
Minimum requirements
WHAT YOULL BRING TO THE ROLE:- Degree in Life Sciences, Pharmacy or Medicine. Advanced degree desirable. Fluency in English (oral and written); additional language(s) a plus.
- Minimum 10+ years of working experience in regulated activities and QA. Good understanding of national and international Health Authority regulations.
- Profound understanding of product development and manufacturing activities. Ability to effectively interact with and present to senior management at all levels, as well as to external audiences and inspectors.
- Clear and open in communication. Able to build effective teams. Strong negotiation and problem solving skills.
- Considerable organization awareness (e.g. inter-relationship of departments, business priorities), including substantial experience working cross-functionally and in global teams. Knowledge and understanding of cultural differences and diversity issues.
Why consider Novartis?
799 million. Thats how many lives our products touch. And while were proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more peoples lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where youre given opportunities to explore the power of digital and data. Where youre empowered to risk failure by taking smart risks, and where youre surrounded by people who share your determination to tackle the worlds toughest medical challenges.
Imagine what you could do at Novartis!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusion workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
Novartis is an equal opportunities employer and welcomes applications from all suitably qualified persons.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Experience Required :
Fresher
Vacancy :
2 - 4 Hires
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