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.

About the Role

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 - 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)

• 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

• 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

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

• English.