Overview:
We are working on behalf of a global biopharmaceutical company in Cork who are actively searching for a QA Representative to join them on a 12 month contract basis as soon as possible.
What to expect day to day:
* Provide Quality leadership, direction, and governance for the specific areas of responsibility.
* Manage quality-related matters specific to area of responsibility.
* Responsible for approving appropriate quality-related documents.
* Review and approval of other key GMP documents such as GMP standard operating procedures, raw material specifications, sampling protocols, master formulas, process flow documents
* Review and approval of GMP documents associated with qualification and validation including IQ/OQ/PQ & validation documents for facility, equipment, computer systems, GMP utilities, analytical methods, and processes, stability data, sampling protocols and Annual Product Reviews.
Requirements:
* Hons BSc, MSc, or PhD in Pharmacy, Chemistry, Engineering, Quality, or related discipline.
* Minimum of 3 years of experience in quality assurance within a biotechnology or pharmaceutical manufacturing environment.
* Strong knowledge of cGMP, FDA, Data Integrity, Quality Risk Management and other biopharmaceutical regulatory requirements.
* Experience working in cross functional teams and proven ability in decision making.
* Experience with Quality Management Systems such as Trackwise and MES is a big plus.