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Vacancy Details

Quality

Quality Assurance Technician – Complaints - Mayo

Contract Type: Permanent
Sector:
Location: Mayo
Date: 1/07/2019
Job Reference: 103604
Contact Name: Clara Burke
Contact Email: engineering@hero.ie

Job Description

Quality Assurance Technician – Complaints – Mayo

Our client, a pharmaceutical company in Mayo are currently looking to recruit a Quality Assurance Technician - Complaints for their Westport site.

Job Summary
The Complaints – Quality Assurance Technician, will report directly to the complaints manager and coordinate the handling of customer complaints investigations, trending and analysis for all commercial & clinical products, working with internal departments on Root Cause Problem Solving cases to ensure implementation of robust Corrective/Preventive action plans and tracking these to completion. The Complaints – Quality Assurance Technician is responsible for opening, tracking and maintain records for complaints received and data entry into complaint handling system. The Complaints – Quality Assurance Technician, is responsible for coordinating cross-functional activities in the investigation of Adverse Event/ Product Quality and customer service complaints and determination of root cause including the coordination of laboratory testing of complaint samples.
The Complaints – Quality Assurance Technician will liaise with corporate QA and Regional offices as part of the case investigation.

Key/Accountabilities: Weight %
This is a list of Core Duties and must not be taken as a definitive list. You may be asked from time to time to undertake other duties, either in or out of your area of responsibility.
  1. People 25% - Provide guidance to department personnel to ensure all complaints are fully investigated and suitable CAPA implemented. Liaise with corporate QA and Regional offices as part of the case investigation.
  2. Strategic 25% - Liaise with internal departments, corporate QA and Regional offices to achieve closure of complaint cases in a timely manner.
  3. Management 40% - Manage the intake, opening, tracking and maintain records for complaints received and data entry into complaint handling system.
  4. Administration/Meetings 10%
    • Complaint trending and monthly reports
    • Quality Defect reports relating to customer complaints/counterfeit cases
    • Attend all meetings as requested by the Complaints Manager or arrange an appropriate deputy.
For example:
  • Complaint trend meetings with Business Unit Personnel
  • Departmental/ANDON Board/OPEX/Project Meetings
  • EHS
Main Contacts
  • Complaints Manager
  • Associate Director, Quality Control
  • Complaint Co-ordinators
  • Business Unit Operations Management Teams
  • QPs in Business Units
Supporting the preparation of documentation on adverse events and quality defects received through the complaints system to ensure timely submission to relevant regulatory agencies. Develop technical product expertise to assess adequacy of complaint information and review of complaint investigations.
  • Support complaint trend analysis and issuance of key reports to relevant departments.
  • Understand and ensure compliance with internal procedures and external global regulatory requirements.
  • Actively participate in departmental Continuous Improvement project and support achievement of department goals and objectives.
Key Requirements
Education and Experience/Knowledge:
Essential
  • Proficient computer skills including: Word, Excel.
  • Excellent written and communication skills
  • Highly motivated and a self -starter
  • Ability to multi-task numerous complaints
  • Good interpersonal skills
  • Good time management and organizational skills
Desirable
  • Previous experience in Pharmaceutical company
  • Bachelor Degree in Sciences or related field
  • Previous experience in the use of Trackwise and Document management systems
Behaviours/Value
  • Relationship Building - Establishing excellent working relationships with cross functional teams involved in complaint investigation. Liaise with corporate QA and Regional offices as part of the case investigation.
  • Communication - Excellent communication and presentations skills, both written and oral.
  • Planning & Organising - Co-ordinate cross-functional activities in the investigation of Adverse Event/ Product Quality and customer service complaints and determination of root cause.
  • Decision Making - Identify and understand issues, problems and opportunities whilst providing a viable solution.
  • Adaptability - Able to work in a fast, dynamic, environment whilst being able to adjust readily to meet unexpected constraints.
  • Passion for results: - Understand and ensure compliance with internal procedures and external global regulatory requirements
  • Receptivity to feedback - Receptive to the ideas of others and welcome and accept constructive feedback, display humility where appropriate.
  • Culture fit - Upholding the values and ethos of the company
  • Other requirement (i.e. travel) - Undertake any training or travel that the role may require

For further information on this Quality Assurance Technician – Complaints in Mayo please contact Clara Burke on 086-8168273/ engineering@hero.ie
Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Clients we are proud to work with

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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”. 


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Ingersoll Rand – Thermo King
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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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Clients we are proud to work with

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