Quality Tech – Complaints
- Dublin Swords, Co Dublin
- Permanent
- Full-time
- The motivation to be an inspiring member of a high performing team.
- The desire to continuously learn, improve and develop.
- Perform supporting activities for general lab readiness, laboratory equipment qualification and method transfers.
- Perform and carry out a variety of routine microbiological analytical techniques including but not limited to environmental monitoring, WFI testing, growth promotion testing, In-process product testing, Final product testing such as bioburden and both Kinetic turbidmetric and MCS rapid endotoxin testing in compliance with GMP requirements.
- To integrate and complete all documention on time and be familiar with LIMS.
- To train and be trained in the use of Rapid microbiology techniques including but not limited to endotoxin testing, water bioburden testing, EM testing, absence of bioburden testing and identification testing.
- Follow up-to-date analytical practices with reference to pharmacopoeias, specifications, regulations and industry standards.
- To update SOP’s and write protocols as required.
- Support the laboratory testing schedule to achieve an efficient QC system.
- Receive and manage samples that come into the lab for stability, in-process and release testing.
- Reagent preparation, cleaning, and routine equipment maintenance.
- Maintain good housekeeping and GLP within the laboratory.
- Calibrate and maintain all designated laboratory instruments.
- Participate in risk assessments, inspections, audits, incident investigations, etc. and implement and follow-up on corrective / preventative measures.
- Ensure training is current for all job functions performed.
- Assist in training new QC Analysts on routine procedures and practices.
- Order, stock and receive laboratory supplies.
- Maintain data integrity and ensure compliance with company SOPs, specifications and cGMP regulations.
- Ensure that cGMP standards are maintained at all times.
- Delivery of area performance to meet or exceed performance or quality goals.
- Promote and participate in the implementation and maintenance of the relevant safety programmes.
- Participate and Comply with the Quality Management System requirements.
- Responsible for driving a culture of Continuous Improvement by deploying Six Sigma tools.
- This position will be on days initially but shift work will be required.
- 1 to 2 years’ relevant experience.
- Experience and critical skills in the area of expertise that add value to the business; ideally analytical microbiology, in a GMP setting.
- Knowledge of cGMP.
- Report, standards, policy writing skills required.
- Lean Six Sigma Methodology experience.
- Understand the specific responsibilities of all departments as they relate to one’s own department, understanding the business processes one’s department supports.
- Effective communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner.
- Third Level science qualification (Microbiology is preferred).