Job Description

Summary About this role:
The Specialist QA Operations manages quality aspects and projects within area of responsibility. Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems.Your Responsibilities:Your responsibilities include, but not limited to:Major accountabilities:

• Oversight of all production and testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance -Support exception investigations -Review and approval of production, QC, and AS and T records -MBR review -Support OpEx improvement projects Qualified Person \xe2\x80\x93 Executes batch release in compliance with registration -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

Key performance indicators:

• On-time and GMP-compliant release of dosage forms -No complaints about inspections by authorities in your own area of responsibility without these being noticed and communicated beforehand -Successfully support continuous improvement projects -Executes batch release in compliance with registration

What you\xe2\x80\x99ll bring to the role:

• Minimum of 3 to 5 years of experience in quality assurance and GMP in the pharmaceutical / biotech industry is preferred
• Minimum Bachelor degree in a scientific discipline (e.g. pharmacy, chemistry, engineering, life science) or similar education; advanced degree in natural or applied sciences preferred
• Enhanced Computer skills
• Proficient in English Required
• Required Competencies:
• Ability to work with tight deadlines as well as strong planning, organizing and time management skills
• Attention to details, dedication to accuracy
• Reliable and with high sense of accountability
• Ability to work independently
• Strong problem solving and analytical skills
• Reliable team-player with strong competence in leading cross-functional teams and operating within a matrix organizational structure
• Strong verbal and written communication skill

Skills:

• Continuous Learning.
• Dealing With Ambiguity.
• Gmp Procedures.
• Qa (Quality Assurance).
• Quality Control (Qc) Testing.
• Quality Standards.
• Self Awareness.
• Technological Expertise.
• Technological Intelligence.

Languages :

• English.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients\xe2\x80\x99 lives. Ready to create a brighter future together?Benefits and rewards: Read our handbook to learn about all the ways we\xe2\x80\x99ll help you thrive personally and professionally:Commitment to Diversity and Inclusion:Novartis is committed to building an outstanding, inclusive work environment and diverse teams\' representative of the patients and communities we serveJoin our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up:Skills Desired Continued Learning, Dealing With Ambiguity, Gmp Procedures, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence

Novartis