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Vacancy Details

Engineering & Technical

Quality Control Technician V - Mayo - 105003

Contract Type: Temporary
Sector:
Location: Mayo
Date: 2/07/2019
Job Reference: 105003
Contact Name: Tommy McKeown
Contact Email: jobs@hero.ie

Job Description

Quality Control Technician V - Mayo - 105003
Quality Control Technician V - 105003

JOB DESCRIPTION

Quality Control Technician V Division/Functional Area: Quality
Department: QC
Location: Westport

JOB SUMMARY:

The Quality Control Technician V will operate on a 1st shift basis and will hold responsibility for QCI activities pertaining to the Global Engineering project through to Pre-Approval Inspection and GMP certification.

The Quality Control Technician V will be responsible for working with the compliance professionals with regards to developing the component incoming inspection specification with the vendor and R&D and assessing the components against the incoming specification.
The Quality Control Technician V will support the Global Engineering Project and work with the Compliance Professional and Production SME with the review and approval of defect sets and maintenance of the same.
The Quality Control Technician V will be required to support the Quality Risk management program with regards to the classification and risk assessments as they relate to the various defect categories. The Quality Control Technician V will be responsible for generation and updating of applicable QC procedures, supporting the commercial production.
The Quality Control Technician V will be responsible for working with Validations and Engineering to determine the equipment required for the incoming inspection of components and the qualification of same.

The Quality Control Technician V will assist the QC Manager in the management of key quality system elements including;

• Non-Conformance and CAPA management;
• Change Control,
• Creation and review of Component Specification Sheets
• In association with the QC Manager the Quality Control Technician V will work to meet company goals and objectives, customer requirements and the regulatory obligations as laid down by the FDA, EU and regional Ministries of Health

Further, the Quality technician ensures that the team work together with the Vendor technician and Vendor professionals to ensure that all component vendor issues are reported and addressed in a timely manner.
In association with the QC Manager the Quality Control Technician V will work to meet company goals and objectives, customer requirements and the regulatory obligations as laid down by the FDA, EU and regional Ministries of Health.

SUPERVISORY RESPONSIBILITY: (IF APPLICABLE)
The Quality control inspector will not have responsibility to hire personnel
KEY DUTIES AND RESPONSIBILITIES: DESCRIBE SCOPE: % of Time or
Importance
Work with the Compliance Professionals in developing component specifications
with Vendors and R&D and assessing components against the component
specification sheets
20%
Defining the Incoming Inspection Requirements of the Components
Assessing and implementing the AQL checks that are required to be performed.
Development of AQL/Reinspection/Reprocessing Procedures
20%
Review and Approval of defect sets and maintenance of life cycle of the same 15%
Work with the Compliance Professional to support the Quality risk management
program in relation to classification of Defects
15%
Generation and updating of applicable QC SOPs and controlled documents 15%
Support the Quality systems including Change controls, non-conformances and
CAPA, Self-Inspections and Regulatory Inspections
15%

JOB QUALIFICATIONS (MINIMUM REQUIREMENTS):
The requirements described in this section are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Education and Experience

• Bachelor’s Degree in Life Science or related discipline
• Minimum of 3 years’ experience working in a GMP regulated environment, preferably in the pharmaceutical or biotechnology industries

Essential Skills, Experience, and Competencies (includes Licenses, Credentials)

• Experience to include, GMP regulated environment, preferably in the pharmaceutical or biotechnology industries
• Experience with supporting regulatory inspections
• Experience with Track wise, SAP and Coral systems
• Experience with regards Visual Inspection and Component Defects
• Experience with regards to Risk Assessments
• Strong communicator with excellent verbal, written and presentation skills


For further information on this Maintenance Technician role in Galway please contact Tommy Mckeown on 086 0100903 / jobs@hero.ie

Check out all our open jobs on our HERO Recruitment website – www.hero.ie
Please Note: HERO Recruitment will not forward your details to any company without your prior approval

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“I have worked with HERO recruitment (formerly HERO recruitment) for a number of years both within my current and previous position. I have always found HERO recruitment excellent to partner with, the consultants know our industry and cultural fit and can therefore successfully source high calibre candidates to match our open vacancies. I find HERO recruitment very professional to deal with and any candidates I interview who are sourced by HERO always have a positive recruitment experience”.

Moira Faherty,
Human Resources Manager
Chanelle Group

“My very first impression was that I was dealing with a recruitment company who were extremely professional, supportive and knowledgeable of the role for which I was applying. Not only were the responsibilities of the role explained to me in great detail, but they also went to great lengths to really understand the depth of my technical, managerial and leadership experience and capabilities. What impressed me the most was their personal touch in building a strong relationship with me as a candidate and in maintaining regular contact with me on the status of the role throughout the application process”.

Adrian Rice,
Engineering Manager 
Boston Scientific

“HERO have been a key strategic recruiting partner to Hollister ULC over many years. During our continued growth and expansion at our facility in Ballina, Hero have worked closely with us to really understand our recruiting needs, the calibre of talent we are looking for, and the fit for our Hollister culture. HERO have successfully sourced and placed candidates for us into Research and Development, Project / Process Engineering, Supply Chain and key Management roles.  They have a very experienced and professional team, and bring an excellent regional, national and international perspective”. 

Tom Horkan,
Asst. HR Manger
Hollister ULC, Ballina, Co. Mayo

"From the first prompt call-back to the ultimate congratulatory call to inform me of a job offer, Karl was an absolute professional; sound advice, solid research and knowledge of companies, unwavering persistence and friendly encouragement. West is best, so for anyone looking for a technical role, talk to Karl"

Fiachra Collins
Computer Vision Algorithm Team Manager
Valeo

“HERO Recruitment continues to be a valued partner in supplying high calibre candidates to all three Boston Scientific sites in Ireland. In particular they have been successful in delivering on specific roles for key project scale-ups. HERO has also provided on-site recruitment presence during increased activity when required and consistently operate in a highly professional and competent manner”.   

Lorraine McDonnell,
Senior Talent Acquisition Specialist
Boston Scientific 

“HERO Recruitment were instrumental in sourcing and delivering key talent to the organisation and enabled us to meet our key deliverables within our start-up phase. They thoroughly understood our culture and constantly over delivered on our expectations. Our partnership with HERO Recruitment has without a doubt been  a professional and collaborative one. HERO exceed themselves in all aspects of recruitment and are an absolute pleasure to work with”.

Christine Power,
VP of Human Resources
Pivot

“HERO recruitment is an extension to our talent acquisition team. From hiring strategy meeting to the induction of the right talent, the HERO recruitment team provide an exemplary service. They are knowledgeable about our business needs, responsive and thorough. A true talent acquisition partner”. 


Orla Keady-Giblin,
Human Resources Manager
Ingersoll Rand – Thermo King
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