QA Process Chemist

A Global Pharmaceutical company based in North Dublin is seeking to recruit a Quality Assurance Chemist to join their QA Process Team on a permanent basis. Reporting to the QA Process Team Lead, the QA Process Chemist will be working closely with the business functions to provide QA support. The successful candidate will have a critical function in identifying, managing and participating in process development activities to optimise existing production processes and procedures to improve quality, increase yields, reduce cycle times and costs.

An exciting and challenging position that offers excellent career development and progression, this is a perfect opportunity to join a select team that has already established itself as a frontrunner leading the way in the Pharmaceutical industries.

Key Responsibilities

• Review and approval of Manufacturing and Cleaning Batch Documentation and associated equipment logbooks in accordance with cGMP
• Batch disposition and preparation of certificates of analysis
• Pre-operative and routine inspections of the plants and facilities - shop floor presence
• Ensure that the work is carried out according to applicable environmental, safety and working regulation and with a strong commitment to promoting work place environment, health and safety
• Use computer-based modelling, simulation & analysis to look for improvement opportunities and to analyze problems. Identify hazards, assess their relative risk and incorporate recommendations into your process designs.
• Drive implementation Lean/Operational Excellence principles across the Technical Analytical Services department
• Ensure use of formal problem-solving techniques, such as root cause analysis (RCA), failure mode effects analysis (FMEA), and/or Lean Six Sigma tools
• Provide support concerning production processes, critical parameters and process knowledge to Production, QC/QA and Technical Service departments
• Initiate and lead continuous improvement activities utilising lean manufacturing methodology
• Investigate and document Deviations and Problem investigations as described in company operating procedures
• Develop Strong expertise and excellent scientific knowledge of process analytical technology and analytical methods

Additional responsibilities might include but are not limited to;

• Preparation of Campaign reports, Process Validation Reports, Process Verification Reports and Annual Product Reviews
• Compilation of Process and Cleaning validation protocols and reports.
• Communicate with all departments on site on a regular basis to ensure timely approval, use and shipping of product
• High level interaction with the various functions on site: Manufacturing, QA and Supply Chain

Education

• The successful candidate will hold a BSc or BEng in Chemistry or a science related discipline and should have at least 2-3 years pharmaceutical experience ideally in a QA role

Key Experience

• The successful role holder will be able to demonstrate excellent time management and organisational skills along with a proven ability to multi-task
• The QA Process chemist will be required to work on his/her own initiative as much as working as part of a team. As such excellent interaction, communication and presentation skills are necessary to be successful in the role
• Experience in all aspects of investigating/troubleshooting and improving manufacturing processes by performing lab, pilot scale investigations from Protocol writing, execution and report writing through to implementing the changes at full scale in a manufacturing environment

Interested?

Please apply below or for more information about the position, contact Jack on 01-6455250