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Quality Inspector - IPQA

  • Image for Employer
    BIOTECH EUROPE MEDITECH INC. LIMITED
  • Image for Job Ref
    Ref: #JOB-2405620
  • Image for Location
    BIOTECH, Roscommon Bus & Tech, Roscommon, Co. Roscommon, F42 P862
  • Image Position
    No of positions: 2
  • Image Part Time
    Paid Position
  • Image Hours per week
    40 hours per week
  • Image for Euro
    34000.00 Euro Annually
  • Image for Published
    Published On: 05 Aug 2025
  • Image for Closing
    Closing On: 02 Sep 2025

In order to work in Ireland a non-EEA National, unless they are exempted, must hold a valid employment permit. Please review the Eligibility and requirements for an employment permit if you are unsure of your eligibility to apply for this vacancy. 


Role: 
Responsible for performing in process quality assurance as well as final product release. 
Supports company goals and objectives, policies and procedures, and quality systems (ISO 13485 and US FDA) 
regulations. 
 
Employees are expected to support the quality concepts inherent in the business philosophies of Biotech Europe Meditech Inc Ltd, including a variety of job-related tasks which may not be specific to this position profile. 

Essential Job Duties And Responsibilities:
 
1. In Process Quality Assurance: 
1.1 Performing IPQA testing & line clearance activities as per the requirements of the relevant procedures. 
1.2 To ensure the aseptic behavior of personnel working in the clean area as per procedure. 
1.3 To review the executed batch manufacturing records (BMR) and batch packing records (BPR) to ensure compliance with manufacturing processes and good documentation practices. 
1.4 To release batches on the SAP System. 
1.5 Create release documentation including Sterility certificates, CoA/CoC and Declaration of conformance as per procedure. 
1.6 Ensure that specifications, quality plans are approved, reviewed and updated as required. 
1.7 Ensure that procedures related to IPQA activities are up to date and reviewed periodically to ensure compliance. 
1.8 Participate in management review and quarterly metrics meetings, by ensuring that the data for IPQA, and product release is maintained, evaluated and relevant actions are taken as required. 
1.9 Give training to IPQA and production personnel for the IPQA activities. 

2. Additional duties and responsibilities 
2.1 Supporting the site CAPA, NC and Change process when required. 
2.2 Supporting the update and management of labelling and artwork for Biotech Europe Products. 
2.3 Identification of systems or work practices which can be improved and recommendation of alternative approaches towards improvement. 
2.4 Provide training and guidance to necessary personnel where required. 
2.5 Update SOP’s as required. 
2.6 Perform additional duties at the request of the direct supervisor / manager. 

Education: 
Diploma/ Bachelor / Masters level degree in pharmaceutical, biochemistry, science or engineering discipline is preferred 

Experience: 
1-2 years previous work experience in a similar work environment is essential. The work environment should include medical device products that are governed by quality management system (QMS) requirements established in ISO 13485 and US 21 CFR 820. Exposure to ophthalmic products is a plus.
  • Sector:

Career Level

  • Executive

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