Qa manager

Novartis pharma gmbh

• Barleben

neues Angebot (27/03/2020)

stellenbeschreibung

Job Description Our External Supply Operations include 1, 000 manufacturers worldwide and manage 3rd party manufacturers for strategic raw materials, drug substances, drug products and finished products. As QA Manager (m/f/d) ESO you will be responsible for managing quality aspects at external suppliers for pharmaceuticals with a complex and high risk product Portfolio and you will also be deputizing the QA Lead

Your Responsibilities

:

your responsibilities include, but are not limited to:

• lead external suppliers qualification process - acts as single point of contact for all quality-related activities at the external supplier - ensure that all aspects of handling, manufacturing and distribution of 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 and initiating external supplier quality risk assessments to be carried out for all external suppliers. if gaps are identified, remediation plans are to be defined 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 - responsible for coordinating and ensuring that quality auditing of external suppliers is carried out according to the novartis quality manual - supports site readiness for regulatory inspections at external suppliers where appropriate - ensures investigations are correctly executed - ensures an oversight of change requests, either from the external supplier or from novartis is maintained and changes are managed according to the quality agreement and novartis sops from receipt, through to the implementation and closure - responsible for assessing quality trends and driving continuous improvement for processes and product quality performance - sign qa agreements if assigned by qa lead eeo statement 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. minimum requirements what you'll bring to the role:
• bachelor or higher in biochemistry, chemistry, microbiology or another related science - 5-8 years experience in the pharmaceutical / device industry - experience in qa operations, production, qc and/or other relevant operational areas, but must include min. of 2 years in qa, 2 years of management and or project management experience or equivalent - thorough knowledge of cgmp requirements - solid understanding of regulatory requirements for commercial products - proven track record with inspections from health authorities is preferred - strong understanding of risk assessment and risk management fundamentals/tools - technical understanding of pharmaceutical processes - team and consensus builder, with definitive and authoritative decision-making ability - fluent in english, german is desired you'll receive:

an open corporate culture, interesting and challenging tasks, attractive social benefits as well as opportunities for individual career growth within an international company. why consider novartis? 799 million. that's how many lives our products touched in 2019. 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! 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 inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential. hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability. 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

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