You manage quality assurance tasks, ensuring compliance in production and testing while supporting project implementations and master data systems. Your role includes coordinating releases and troubleshooting material issues.
Anforderungen
- •QC/QA in pharmaceutical industry
- •Experience with GMP procedures
- •Technological expertise and intelligence
- •Ability to deal with ambiguity
- •Continuous learning capability
- •Collaboration across boundaries
- •English and German language required
Deine Aufgaben
- •Prepare and coordinate release data and documents.
- •Support QA compliance through audits and submissions.
- •Assist with project support for new labs and systems.
- •Oversee production and testing activities for compliance.
- •Support master data systems like SAP and GLIMS.
- •Compile and maintain master data sheets.
- •Evaluate and implement changes as a subject matter expert.
- •Manage material implementations and troubleshoot issues.
- •Ensure timely delivery of key performance indicators.
Deine Vorteile
Market-competitive base salary
Attractive incentive program
Modern company pension scheme
Childcare facilities
Learning and development opportunities
Worldwide career possibilities
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