You prepare and coordinate releases, support QA audits, oversee production activities, and manage master data systems for compliance.
Anforderungen
- •QC/QA in pharmaceutical industry
- •Experience with GMP Procedures
- •Quality Assurance and Quality Control testing
- •Quality standards
- •Technological Expertise
- •Dealing with ambiguity
- •Continuous learning
- •Collaboration across boundaries
- •English language required
- •German language required
Deine Aufgaben
- •Release preparation and coordination
- •Troubleshoot release organization issues
- •Support QA compliance audits
- •Assist with new labs and systems support
- •Oversee production and testing activities
- •Ensure cGxP compliance and data integrity
- •Support exception investigations
- •Manage master data systems like SAP and GLIMS
- •Implement and evaluate change tasks
- •Serve as SPOC/SME for master data topics
- •Oversee material implementations and troubleshooting
- •Support preparation of key performance indicators
Deine Vorteile
Marktgerechtes Grundgehalt
Attraktives Anreizprogramm
Modernes Betriebsrentensystem
Kinderbetreuungseinrichtungen
Lern- und Entwicklungsmöglichkeiten
Weltweite Karrieremöglichkeiten
Original Beschreibung
# QA Specialist Operations
**Kundl** | **Full time**
**Band**
Level 3
**Job Description Summary**
QA Operations Specialist in the Raw Material & Consumables Release Group.
**Job Description**
**Major accountabilities:**
* Release preparation (collection and completion of data, documents and information) & coordination & troubleshooting (interactive communication & release organization)
* QA compliance support (audits for DSK/DSS/DPS, submissions etc.)
* Project support (support of new labs, departments, systems into routine etc.)
* Oversight of all production and testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance; support exception investigations
* Support of master data systems at our production site: SAP, GLIMS etc.; responsible for CP implementations and stability studies
* Compilation / check of master data sheets (master data maintenance); Change evaluations / implementation tasks, being a SPOC/SME for all related topics
* Responsible for material implementations (raw materials, consumables etc.), troubleshooting & Project support
* Key performance indicators: deliver preparation on time, support raw material and consumables release and projects
**Minimum Requirements:**
* QC/ QA in pharmaceutical ind./ biotech with environmental monitoring
* Experience with GMP Procedures, Quality Assurance (QA) and Quality Control (QC) testing, Quality standards
* Technological Expertise and technological Intelligence
* Required skills: Dealing with ambiguity, able to learn continuously, collaborating across boundaries
* English and German language required
**Skills Desired**
Continued Learning, Dealing With Ambiguity, Gmp Procedures, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence