Beschreibung

As a QA Operations Expert, you will play a vital role in ensuring product quality and compliance with global standards. Your daily tasks will involve overseeing GxP functions, managing regulatory requirements, and collaborating on audits to uphold the highest quality assurance practices.

Anforderungen

• •University Degree in Pharmacy, Biochemistry, Biotechnology, Chemistry, Microbiology or equivalent
• •Professional experience in pharmaceutical industry with direct experience with Pharmaceuticals, Biopharmaceutical or API products and at least 2 years within QA
• •Thorough knowledge of cGMP requirements and proven track record with FDA / EMA and other Health Authorities
• •Knowledge of GMP and Management of Quality Audits
• •Flexibility to work in a fast paced, quickly changing work environment
• •Knowledge of Manufacturing Process/ Product Expertise
• •Fluent knowledge of English and German (written and spoken)
• •Continued Learning, Employee Performance Evaluations, Gmp Procedures, Managing Ambiguity, People Management, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technical Knowledge, Technological Intelligence

Aufgaben

• •Oversee GxP functions to ensure product quality
• •Implement and govern practices from the Novartis Manufacturing Manual
• •Act as the release responsible person for regulatory compliance
• •Ensure local HA registration and qualified state of facilities
• •Review and approve PQR and APQR documents
• •Manage exceptions, deviations, and complaints
• •Define and implement CAPAs effectively
• •Ensure compliance with cGxP and regulatory requirements
• •Adhere to HSE guidelines and requirements
• •Collaborate in internal and external audits
• •Ensure Quality Assurance Agreements with third parties
• •Review and approve MBR, specifications, and test methods
• •Participate in the compilation and approval of GxP documents
• •Support transfer projects and validation studies
• •Author SOPs and other GxP documents as needed

Benefits