347945BR
Jul 08, 2022
Poland

Job Description

Operational Quality Assurance Specialist, Qualified Person

110,000 people of more than 140 nationalities! This amount of people works at Novartis around the world.

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 team’s representative of the patients and communities we serve.

Minimum Requirements

What you’ll bring to the role, essentials:

• 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
• knowledge of Microsoft Office
• the ability to search for solutions, openness to changes,, teamwork player, analytical thinking, ability to make decisions and solve the issue, work under the time pressure, good communication skills, building positive relationships and determination to deliver the gools



Why Novartis?

769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
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 do here at Novartis!
Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

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
Novartis Technical Operations
NTO QUALITY
Poland
Warszawa
Quality
Full Time
Regular
No
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347945BR

Operational Quality Assurance Specialist, Qualified Person

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