Novartis Pharmaceuticals Quality Assurance Manager - ESO in Hyderabad, AP, India
365 days a year, our global manufacturing and supply network operates to ensure our patients have the treatments they need to live longer, healthier lives.
Responsible for handling quality aspects at external suppliers for Biopharmaceutical / Pharmaceutical / Devices and to ensure that the operational business is in compliance with cGMP, the Quality Assurance Agreement, regulatory requirements and the Novartis Pharma Quality Manual and is conducted according to the relevant SOPs.
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. 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 supervised to ensure that issues are suitably addressed.
•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 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. Handle 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, handle action plans and follow up on agreed upon CAPAs. Ensure site readiness for regulatory inspections at External suppliers where appropriate.
•Handles 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.
Quality Assurance Manager - ESO
What you’ll bring to the role:
•Bachelor or higher degree; preferred in Biochemistry, Chemistry, Microbiology or another related science Fluent in speaking / writing in English
•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.
•Consistent 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.
Competitive salary, annual bonus, pension scheme, share scheme, health insurance, 29 days annual leave, flexible working arrangements, subsidized dining facilities, employee recognition scheme. Find out more about Novartis : https://www.novartis.com
Why consider Novartis?
799 million. That’s how many lives our products touch. And while we’re 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 people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
Imagine what you could do at Novartis!
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
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