Quality Engineer

My Galway based client has a vacancy for a Quality Engineer:

Co-ordination and implementation of Process Analytical Technology and Statistical Process Control
Preparation and co-ordination of Process, Equipment and Software validation protocols and validation activities in conjunction with R&D and Engineering
Provide quality engineering support to manufacturing
Understand and ensure compliance with the company's and external regulatory quality systems requirements
Use and establish analysis techniques and other quality control tools to aid in decision making
Identify opportunities for process and quality system improvements and work with task teams in Implementation
Investigating root cause of quality issues and following through on corrective actions to prevent reoccurrence

Qualifications & Experience:

Will possess a Bachelor of Science Degree in Engineering / Technology particularly in Chemistry or Polymer Technology.

2 / 3 years experience in a Pharmaceutical Technology, Combination Product or related environment with direct experience in a QA environment (GMP regulated). Knowledge of regulatory requirements and guidelines, namely CFR Parts 210, 211 and 820, ICH and ISO13485 is necessary.

Experience of working with pharmaceutical chemistry data is an advantage. Excellent interpersonal and communication skills including report writing is necessary.

Experience in conducting Stability studies and knowledge of Cleaning Validation would be an advantage.

Salary dependent on experience