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Process / Quality Engineer

I8172

Process/Quality Engineer (Kerry) The successful Process/Quality Engineer will provide support and expertise to manufacture and supply quality pharmaceutical products. The Engineer will have at least 2 years’ experience in the pharmaceutical, chemical manufacturing and/or medical device operation (e.g. Quality, Science, Engineering etc) or a similar operating environment which includes experience in a Quality function. The Process/Quality Engineer will be an active member within the cross functional Team providing independent quality support, guidance and expertise. The Quality Engineer will drive a culture of continuous improvement building a High Performance Organisation. Primary activities/responsibilities: Preparation of GMP Procedures (& associated documents) for the Business Unit. Shared responsibility for review of batch records within the Business Unit. Ownership for the key quality systems in the Business Unit including the update and communication of Quality metrics. Preparation, Review & approval of key quality system deliverables including Change control/RTC’s, Trackwise, Deviations, CAPAs. Participation in inspections of site by Regulatory Bodies / third parties. Investigation and reporting on Customer Complaints. Ensure supply of high quality product through the implementation and oversight of the Quality Management System, ensuring tasks are performed as per procedure, by assigned target dates, issues are escalated and resolved and work Performed in an organised and structured manner. Champion the highest Quality and Compliance standards for the Business Unit. Qualifications: • Degree or 3rd level qualification (Science, Quality, Engineering). • Desirable evidence of Continuous Professional Development. • Process and Quality background. • Demonstrated ability to fully realize improvement initiatives. • Proven track record of providing independent Quality expertise to Manufacturing functions. • Demonstrated successes in a team environment, such as project teams, Six Sigma team, etc.

Category:
Engineer Chemical
Location:
Munster
Years of Experience Req.:
2 years +
Date Posted:
15/07/2020
Days Remaining:
22
Employment Type:
Contract
Education Level Req.:
Third level Degree (Level 8)

Process/Quality Engineer (Kerry)

The successful Process/Quality Engineer will provide support and expertise to manufacture and supply quality pharmaceutical products. 

The Engineer will have at least 2 years’ experience in the pharmaceutical, chemical manufacturing and/or medical device operation (e.g. Quality, Science, Engineering etc) or a similar operating environment which includes experience in a Quality function.

 

The Process/Quality Engineer will be an active member within the cross functional Team providing independent quality support, guidance and expertise. The Quality Engineer will drive a culture of continuous improvement building a High Performance Organisation.

 

Primary activities/responsibilities:

Preparation of GMP Procedures (& associated documents) for the Business Unit.

Shared responsibility for review of batch records within the Business Unit. 

Ownership for the key quality systems in the Business Unit including the update and communication of Quality metrics.

Preparation, Review & approval of key quality system deliverables including Change control/RTC’s, Trackwise, Deviations, CAPAs.

Participation in inspections of site by Regulatory Bodies / third parties.

Investigation and reporting on Customer Complaints. 

Ensure supply of high quality product through the implementation and oversight of the Quality Management System, ensuring tasks are performed as per procedure, by assigned target dates, issues are escalated and resolved and work Performed in an organised and structured manner.

Champion the highest Quality and Compliance standards for the Business Unit.

 

Qualifications:  

•  Degree or 3rd level qualification (Science, Quality, Engineering). 

•  Desirable evidence of Continuous Professional Development.

•  Process and Quality background.

•  Demonstrated ability to fully realiz225629.203726e improvement initiatives.

•  Proven track record of providing independent Quality expertise to Manufacturing functions.

•  Demonstrated successes in a team environment, such as project teams, Six Sigma team, etc.

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