QA Specialist- Microbiological Qaulity Assurance

Procella Therapeutics AB

Sweden - Stockholm

Apply now QA Specialist - Microbiological Quality Assurance
On behalf of our client Procella Therapeutics we are now recruiting a highly motivated QA Specialist -Microbiological Quality Assurance.
Procella Therapeutics provide advanced capabilities within stem cell therapy development and have inhouse cGMP manufacturing. Procella has globally licensed cardiac stem cell therapy in clinical stages (collaboration with AstraZeneca) and a growing pipeline of stem cell therapies.

About The Position
This is a role for someone who is ready to work in a QA role with many internal and external contacts. At Procella you will be part of a great team with high competence, and you will be working at a patient-focused, growing and developing company that makes a difference. As a QA Specialist – Microbiological Quality Assurance, you will provide QA oversight towards GMP clean rooms (grade D - Grade A), while ensuring cGMP of internal manufactured products. This role will work closely with cross functional teams internally (development, manufacturing, QC). Reporting to the Head of Quality and Qualified Person, this full-time position is located at Procella Headquarters in Tullinge, Greater Stockholm Area.

Responsibilities
Provide Quality oversight for environmental monitoring of manufacturing facility and cleaning verifications

QA representative in validation activities (CV) of facilities, equipment/instruments, material transfer and certification activities (gowning)

Ensure facility and quality systems state of compliance with internal requirements and appropriate regulations

Lead/Participate in developing action plans to correct deficiencies to ensure the adequate microbiological quality of the site facilities, utilities, processes, and products

Analyze and interpret environmental monitoring data, identify trends, and implement adequate corrective actions

QA lead in design and development of Aseptic Process Simulations / Media Fills

Handle various documentation revisions (including SOPs etc.)

QA member in various cross-functionally teams and projects (tech transfers) to ensure microbial contamination prevention and control requirements are met for new product introductions, facility adaptations, and process changes

Act as an expert and be an advisor regarding GMP in quality issues from a environmental view

Develop and deliver training programs to facility staff on contamination prevention and control, Cleanroom behavior, microbial theory and hygiene best practices