Job Title: Parenteral Quality Consultant
Location: Alzey, Germany
Overview:
The Parenteral QA Floor Representative will provide on-the-floor quality oversight for the manufacturing of sterile injectable drug products. This role ensures compliance with regulatory requirements and best practices for formulation, filling, and isolator technology.
Key Responsibilities:
* Provide real-time QA oversight for parenteral manufacturing, including formulation, filling, and sterile filtration.
* Ensure compliance with Good Manufacturing Practices (GMP) and sterile processing requirements.
* Support deviation management and corrective actions to maintain operational excellence.
* Guide production teams in proper use of isolator technology, cleaning validation, and sterilization validation.
* Ensure effective execution of visual inspection processes for sterile drug products.
* Work cross-functionally with engineering, operations, supply chain, and technical services teams.
* Assist in training efforts to expand the capabilities of site personnel.
Qualifications:
* Bachelor's degree in a relevant field (or equivalent experience).
* Experience in pharmaceutical QA oversight, particularly in sterile injectable manufacturing.
* Strong understanding of single-use disposable systems (SUD), CIP/SIP processes, and isolator technology.
* Experience with visual inspection and aseptic processing.
* Ability to work collaboratively and influence teams without direct authority.
* Flexible schedule to support 24/7 operations as required.