QA Operations Expert(m/w/x)

# QA Operations Expert **Schaftenau** | **Full time** **Band** Level 4 **Job Description Summary** QA Operations Expert is responsible for managing quality aspects within area of responsibility and to ensure that the operational business is in compliance with cGMP (Current Good Manufacturing Practices), the Quality Assurance Agreement, regulatory requirements and the Novartis Quality Manual and is conducted according to the relevant Standard Operating Procedures. **Job Description** **Key Responsibilities:** Your responsibilities include, but are not limited to: * Oversight of all production and testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance * On-time and GMP-compliant release of dosage forms * Support exception investigations * Review and approval of production, QC, and AS and T records and 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) * Successfully Support continuous improvement Projects **Essential Requirements:** * University Degree in Pharmacy, Biochemistry, Biotechnology, Chemistry, Microbiology or equivalent * KLL - Kontrollaborleiter(in) qualification required for the role * Professional experience in Pharmaceutical industry, Biopharmaceutical or API products and at least 2 years within QA, thorough knowledge of cGMP requirements * Accountability: takes responsibility for his/her tasks and is reliable * Decision Making: correctly interprets analyses and evaluations and correctly identifies which measures should be taken * Ability to work in a team: has the ability to contribute constructively and reliably in a group as well as results driven when motivating himself/herself and others to obtain good results and ensures observance of ethical and legal principles * Customer focus: gives customer satisfaction highest priority and continuously striving for improvement and quality focus when providing the highest quality products and services, which meet the needs and requirements of internal and external customers * English and German language required **Skills Desired** Continued Learning, Dealing With Ambiguity, Employee Performance Evaluations, Gmp Procedures, People Management, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence