Job description

GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services (CQV) to the life sciences and technology sectors. We partner with many of the world’s largest life science & technology companies who entrust in us to deliver their most strategic and important projects with our technically strong personnel ensuring all important activities meet both current requirements and client’s needs.

We are hiring for a Quality Specialist for the Sligo region.

Job Requirements

• Ensure Quality System documentation is thorough, complete, and compliant.
• Complete Incoming Inspection Reviews of Incoming Material
• Complete in-process and final release product testing per the relevant approved specifications and procedures.
• Generate batch records for as required in support of manufacturing process orders.
• Complete incoming product testing per the relevant approved specifications and procedures.
• Participation in continuous improvement programs to implement improvements in the quality, safety, environmental and production systems at the site.
• Review batch records including In process Batch Records/Testing Records
• Providing metrics for inclusion in the management review, monthly reports etc.
• Final Product Batch Records/QC Testing Records ensuring all Batch Record documentation is compliant to requirements
• Complete disposition decision for the batch.
• Ensure Management is kept informed of all product failures to ensure corrective/preventive action and product containment is taken where necessary.
• Support change management process as part of role and ethos of continuous approval
• Ensure compliance to training requirements is maintained.

Education & Key Skills

• Third level qualification in a Science/Engineering discipline
• 3-5 yrs plus professional experience, preferably in a medical device or manufacturing environment
• Shows a high level of attention to detail and tenacity to ensure any issues noted are elevated to the Operations Quality Team Leader.
• Highly motivated, enthusiastic, energetic individual with a goal focused attitude.
• Promote a continuous improvement culture
• Strong planning / organisational skills.

#INDHP

Job Type: Full-time

Schedule:

• Day shift

seankuhnke.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, seankuhnke.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, seankuhnke.com is the ideal place to find your next job.