347682BR
Jun 30, 2022
Poland

Job Description

Operational Quality Assurance Specialist, Stryków, Poland

180! Our products are available in so many countries. We mark our presence in Poland at almost every stage of a medicine's life - from clinical research, through production, to providing medicines to patients and the latest medical knowledge to doctors.
Now you can join as an Operational Quality Assurance Specialist.

Your key responsibilities:

• Making independent decisions on batch certification and release to the market or rejection of batch of medicinal products
• Participation in quality processes, including risk analysis, change control, root cause investigation (after deviations, out-of-specification results (OOS); complaints), corrective and preventive actions (CAPA); product quality review (PQR), inspections / audits
• Verification and approval of production documentation related to the manufacturing / packaging process
• Verification and approval of instructions and procedure
• Improvement of the Quality System in accordance with the current requirements of the pharmaceutical law in area of manufacturing / packaging of medical products,
• Participation in improvement projects, related with production and quality processes
• Participation in inspections and quality audits (GxP)
• Conducting internal training related with GMP requirements

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

From the candidate we require:

• Higher education - preferred: Medicine / Pharmacy / Biology / Biotechnology / Chemistry or related, postgraduate studies if it is necessary to supplement education, knowledge, and skills according to Polish Pharmaceutical Law
• Minimum 2 years of professional experience in Quality Assurance, Quality Control, Certification & Release of Product (pharmaceutical industry)
• Comply with requirements for Qualified Person/ QP (specified in Article 48 (1) and (2) of the Act of 6 September 2001 – Polish Pharmaceutical Law (Journal of Laws of 2019, item 499)
• Knowledge of the requirements of pharmaceutical law and good manufacturing practice (GMP) for medicinal products
• Knowledge of English
• Knowledge of German (written and spoken) will be an advantage
• Teamwork player with the openness to changes.


Desirable requirements:
• Analytical thinking, ability to make decisions and work under the time pressure
• Good communication skills, building positive relationships and determination to deliver the gools

Why consider Novartis?
766 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.

Novartis are an equal opportunities employer and welcome 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
Novartis Technical Operations
NTO QUALITY
Poland
Strykow
Quality
Full Time
Regular
No
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347682BR

Operational Quality Assurance Specialist, Stryków

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