Novartis QA Job For BSc, MSc Biochem & Microbiology – Apply Online

377153BR

Quality Assurance Manager – API

Job Description

1996! In this year Sandoz initiated the world’s first biosimilar development program. Over 20 years of experience in biosimilar development have equipped us with extensive knowledge and world-class expertise and capabilities in the development, manufacturing and commercialization of biosimilar medicines to the healthcare community and patients worldwide. This opportunity is waiting for you to contribute to Sandoz success story in the area of biosimilar toward the future, at the same time it becomes also the right step up in your career within clinical development!

Your key responsibilities:

Your responsibilities include, but not limited to:

• Lead External Suppliers Qualification process. Acts as Single Point of Contact / SPOC for all quality related activities at the External Supplier. Provide the quality presence and in-put to Technical meetings with the External suppliers and establish good working relationships with clear communication and defined actions and goals.
• Ensure that all aspects of the handling, manufacturing and distribution of biopharmaceutical / pharmaceutical products are in compliance with the Novartis Pharma Quality Manual, the effective Quality Agreement that they meet relevant cGMP regulatory requirements and are conducted according to local SOPs.
• Responsible for driving / initiating External Supplier Quality Risk assessments to be carried out for all External Suppliers. Gaps are Quality Systems to be identified with an evaluation of the associated risks. Remediation plans are to be defined and execution is to be monitored to ensure that issues are suitably addressed
• Ensure that a valid QA agreement defined in line with the requirements of the Global template is in place which clearly defines cGMP roles and responsibilities between Novartis and the External Supplier, as well as Product details and requirements.
• Request, review and process GMP documentation as defined by the Quality Agreement and Novartis SOPs. Manage the quality aspects of the relationship in accordance with the effective Quality Agreement. Perform the required periodic review and make recommendations for amendments to the agreement based on identified needs and issues.
• Responsible for coordinating and ensuring that Quality auditing of External suppliers is carried out according to the Novartis Quality Manual – maintain an annual auditing program, participate in and/or lead audits, manage action plans and follow up on agreed upon CAPAs. Ensure site readiness for regulatory inspections at External suppliers where appropriate.
• Manage critical quality issues (deviations, complaints, recalls, counterfeits and product tampering, stability failures, etc) according to the Quality Agreement and the Novartis Quality Manual. Ensure investigations are correctly executed.
• Responsible for assessing quality trends and driving continuous improvement for processes and product quality performance. Stability reports and PQR’s, Ensure that the External Supplier provides the required product review or the data as specified in the relevant Quality Agreement on an annual basis. Critically assess the performance of the product and process and provide the assessment to the report annually.

Minimum requirements

What you’ll bring to the role:

• 5-10 years’ experience in the pharmaceutical industry, with direct experience with Pharmaceutical/Biopharmaceutical/API products. Experience in QA Operations, production, QC and/or other relevant operational areas, but must include minimally 5 years in QA, and 3 years of management and or project management experience.
• Thorough knowledge of cGMP requirements. Strong understanding of regulatory requirements for commercial products.
• Proven track record with FDA, EMEA and other Health Authorities. Strong understanding of risk assessment and risk management fundamentals/tools.
• Strong Technical understanding of pharmaceutical processes. Team and consensus builder, with definitive and authoritative decision making ability.

Desirable: Bachelor or higher degree; preferred in Biochemistry, Chemistry, Microbiology or another related science

Why Sandoz?

500 million patients were touched by Sandoz generic and biosimilar medicines in 2021 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.

How will we do this? 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 achieve here at Sandoz!

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 [email protected] 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 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

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Possible interview questions

1. Can you describe your experience in quality assurance operations within the pharmaceutical industry, specifically with Pharmaceutical/Biopharmaceutical/API products? Answer: Yes, I have 5-10 years of experience in the pharmaceutical industry, with a focus on quality assurance. I have worked in various operational areas, including QA Operations, production, and QC. My direct experience with Pharmaceutical/Biopharmaceutical/API products has allowed me to develop a thorough understanding of cGMP requirements and regulatory compliance. I have also successfully worked with FDA, EMEA, and other Health Authorities.
2. How would you ensure that the handling, manufacturing, and distribution of biopharmaceutical/pharmaceutical products are in compliance with quality standards and regulatory requirements? Answer: To ensure compliance, I would adhere to the Novartis Pharma Quality Manual and relevant cGMP regulatory requirements. I would establish and maintain effective Quality Agreements with external suppliers, clearly defining roles and responsibilities. Regular audits would be conducted to assess compliance, and any identified gaps or issues would be addressed through remediation plans. Additionally, I would review and process GMP documentation in accordance with the Quality Agreement and SOPs.
3. Can you provide an example of a critical quality issue you have managed, such as deviations, complaints, or recalls, and how you handled it? Answer: In a previous role, we encountered a stability failure issue with a product. I immediately initiated an investigation following the Quality Agreement and Novartis Quality Manual guidelines. Through a thorough assessment, we identified the root cause and implemented corrective actions to prevent recurrence. I ensured that the investigation was executed correctly and followed up on any required CAPAs. The lessons learned from this experience were incorporated into our continuous improvement processes.
4. How do you stay updated with regulatory requirements and industry best practices in quality assurance? Answer: I am committed to ongoing professional development and staying updated with regulatory requirements and industry trends. I actively participate in relevant conferences, workshops, and training programs to enhance my knowledge. I also engage with professional networks, subscribe to industry publications, and follow regulatory updates from authorities such as FDA and EMEA. Continuous learning and staying abreast of changes in the field are essential to my role as a quality assurance manager.
5. Can you share an example of a situation where you drove continuous improvement for processes and product quality performance? Answer: In a previous role, I implemented a comprehensive quality trend analysis program to identify areas for improvement. By analyzing data and conducting thorough assessments, I pinpointed process inefficiencies and suggested targeted improvements. Through collaborative efforts with cross-functional teams, we successfully implemented process optimizations, resulting in enhanced product quality performance and increased efficiency. Regular stability reports and PQRs were generated to assess the effectiveness of the improvements and identify further opportunities for enhancement.

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