About the role
Location: Austria, Tyrol, Schaftenau #LI-Hybrid We We are seeking a QA Operations Expert (m/f/d) to help us with the implementation of quality assurance tasks such us release process of compounding / filling / inspection / packaging products and further development of the existing quality system. This role will work directly with the QA Operations Team and reports to the QA Operations Team Leader. Key Responsibilities: • Ensuring GMP Compliance in Production.• Participation in the preparation and approval of validations (e.g. process, mediafills, smoke studies), transfers and SOPs
• Approval of specifications, sampling instructions, test methods and other quality control procedures; as well as participation in and evaluation of changes in the process and specifications.
• Ensuring the evaluation of batch production and testing protocols.
• Timely decision on the use of intermediate and bulk products.
• Control and oversight of aseptic processes.
• Assisting in the preparation of QA agreements and answers to health authority questions, as well as preparation and participation in audits and inspections.
• Performance and approval of investigations of deviations and Out Of Specifications and Expectations (OOS and OOE), and support in complaint investigation, together with the evaluation and approval of CAPA measures and risk assessments.
• Alignment and improvement of existing processes and procedures to establish the Drug Production Schaftenau quality system.
Role Requirements
Essential Requirements: • University Degree in Pharmacy, Biochemistry, Biotechnology, Chemistry, Microbiology or equivalent.• Professional experience in Pharmaceutical industry, Biopharmaceutical or API products.
• Excellent working knowledge and experience of pharmaceutical QA and cGMP standards.
• Proof of qualification and nomination as Control Laboratory Manager, Kontrollaborleiter/in (KLL), according to Regulation on Operating Instructions for Medicinal Products (AMBO).
• English & German proficiency. Why Novartis? Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.
In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development opportunities as well as worldwide career possibilities within the Novartis group. In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is € 60.212,18year (on a full-time basis). In most cases, the actual salary will be higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.
We are open for part-time and job-sharing models and support flexible and remote working where possible. Adjustments for Applicants with Disabilities: If because of a medical condition, physical disability or a neurodiverse condition you require an adjustment during the recruitment process, please reach out to E-Mail auf sjobs.brassring.com ansehen and let us know the nature of your request as well as your contact information. The support which we can provide will include advice on suitable positions as well as guidance at all stages of the application process. Austrian law provides candidates the opportunity to involve the local disability representative, Behindertenvertrauensperson (BVP), in the application process. If you would like to request this, please let us know in advance as a note on your CV. 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:
Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.Die Stellenanzeige wurde vor vor 2 Monaten veröffentlicht
Ähnliche Jobs, die für Sie interessant sein könntenBasierend auf das Stellenangebot QA Operations Expert (m/f/d) in Langkampfen
60.212,18€ pro Jahr
...for an experienced Computerized System Expert (m/f/d) to join our team in Schaftenau. You may... ...limited to: • Supporting the departments in operating an ERP system (SAP) as a SuperUser •... ...of BioInject production with IT and QA compliance • Providing specialized support...EmpfohlenTeilzeitarbeitHomeoffice58.199,96€ pro Jahr
Summary Manufacturing Systems Expert (m/w/d), Schaftenau, Tirol, Österreich Die Position: Im herzen Tirols stellen wir lebensrettenden Medikamenten für zahllose PatientInnen durch die ganze Welt her. Wesentlicher Teil des Produktionsprozesses hat das Manufacturing...EmpfohlenAusbildungsplatzTeilzeitarbeitWeltweitHomeoffice64.023,54€ pro Jahr
...Supporting change control and inspection management within the QA Compliance Team. Relocation for this role will not be supported... ...(German desired). More than 3 years of experience in an operational GxP area, in Manufacturing, Development, QA or Regulatory Affairs...Empfohlen60.600€ pro Jahr
Summary QA Operations Expert ensures QA Operation activities in the area of responsibility are executed according to cGxP standards. About the Role Major accountabilities: Oversight of all production & testing activities, ensures compliance...EmpfohlenTeilzeitarbeitHomeoffice54.735,38€ pro Jahr
...Requirements Essential Requirements: • University degree in technical or business discipline, science or medicine. • Manufacturing/operations management experience. • Proven change management and strong communication skills. • Ability to be flexible and adapt to...EmpfohlenTeilzeitarbeitHomeoffice55.610,59€ pro Jahr
...team make sure that our syringes, pens, autoinjectors etc. meet the highest customer standards. You will do this as part of a team of experts in the device development teams by developing, planning, and performing the right tests in the Device Testing Laboratory in...TeilzeitarbeitHomeoffice- ...mittels Zellkulturprozessen modernste Wirkstoffe hergestellt werden sollen. Ergreifen Sie die Chance, als Manufacturing Systems Expert (m/w/d) für Qualifizierungen und Validierungen dazu beizutragen, den Grundstein für die Medikamentenherstellung in unseren...TeilzeitarbeitWeltweitHomeoffice
- ...sind Magenta. Mit einer Lehre bei Magenta Telekom hältst du die digitale Zukunft in deinen Händen. Als zukünftiger Future Customer Expert bei Magenta begeisterst du Kundinnen und Kunden für unsere Produkte und Serviceleistungen. Dabei kombinierst du Know-how mit starker...AusbildungsplatzPraktikumsplatzLehre
54.735,38€ pro Jahr
...molecule. You'll be responsible for generating and interpreting data, and communicating results to our technical teams. As the MS expert, you'll help decide on next steps. You'll also prepare technical documents and reports, participate in function-specific sub-teams,...TeilzeitarbeitHomeoffice54.735,38€ pro Jahr
...About the role Manufacturing Systems Expert (m/w/d), Schaftenau, Tirol, Österreich Die Position: Industrie 4.0! Werde Teil eines Digitalisierungs- und Automatisierungsteams, das mit seiner vielfältigen Expertise im Bereich der Medikamentenherstellung die Zukunft...TeilzeitarbeitWeltweitHomeoffice40.960€ pro Jahr
...About the role About the role: Associate Expert Science & Technology(f/m/d), Kundle, Austria, #LI-Hybrid. We require an Associate level... ...procedures, reports and /or instructions and/or Standard Operating Procedure’s • Successful execution of assigned tasks within...TeilzeitarbeitHomeoffice43.548,4€ pro Jahr
...Digitally & Technologically savvy, specifically skilled with digital tools and experience of ERP systems. • You will be skilled in operational performance and change management along with Franchise Strategy Prioritization and a good knowledge of organizational structures...TeilzeitarbeitHomeoffice60.600€ pro Jahr
...Summary The Analytical Science and Technology (AS&T) Expert is responsible for the rollout and management of the local Digital QC... ...) End user training and knowledge transfer to the busines Operational first level support and trouble shootin Incident investigation...TeilzeitarbeitHomeoffice60.600€ pro Jahr
Summary The Analytical Science and Technology (AS&T) Expert is responsible for coordination and management of analytical activities of commercialized products as well as to provide scientific analytical support. About the Role Major Accountabilities...TeilzeitarbeitHomeoffice- Deine Rolle im Team Aufbau und Mitgestaltung des gesamten Lebenszyklus komplexer Data Science und Maschine Learning Projekte von der Projektidee bis zur Industrialisierung Definition und Auswertung von Messgrößen mittels Data Science Methoden Entwicklung von Prozessen...VollzeitAusbildungsplatz
66.800€ pro Jahr
Summary 80 + 150 = Betriebsfeuerwehr – 80 Mitglieder decken pro Jahr ca. 150 Einsätze zu jeder Tages-und Nachtzeit ab – als Experte für chemische Sicherheit und Gefahrgut kennst Du die stofflichen und anlagentechnischen Gefahrenquellen der Betriebe im Detail und...AusbildungsplatzTeilzeitarbeitWeltweitHomeoffice
Wollen Sie mehr Stellenangebote erhalten?
Abonnieren Sie und erhalten Sie ähnliche Stellenangebote wie QA Operations Expert (m/f/d). Seien Sie der Erste, der sich bewirbt!