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Vacancy Details

Quality

Quality Systems Specialist (days) - Cork

Contract Type: Contract
Sector:
Location: Cork
Date: 19/03/2019
Job Reference: 103121
Contact Name: Orla Crowley - Healy
Contact Email: talent@hero.ie

Job Description

Quality Systems Specialist (days)

Our client is a pharmaceutical company based in Cork looking for A Quality Systems specialist

Department: Quality Systems
Report to: QS Manager




Job Summary
  • The candidate must have a broad knowledge of cGMPs and prior experience of working in HPRA/FDA regulated facility. The candidate must also build customer value through effective collaboration and influencing others, as well as consistently delivering on goals and objectives under minimal supervision.
  • The individual will be responsible for (some of the following):
  • Internal Audit Program
  • Management of the document management system- which can include supporting and advising Documentation Control administration personnel, as required
  • GMP service providers program
  • Managing the non-conformance system and CAPA process
  • Quality agreement process
  • Change control process and system
  • Supporting site regulatory inspections where appropriate
  • Supporting the site induction process
  • Metrics and report generation from the quality systems

Responsilbites:
  • Reporting to the QS Manager, the person will be responsible for the following:
  • Providing support, direction and training to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met.
  • Partners with other departments to ensure that compliance systems are implemented in an efficient manner.
  • Supports the development and management of GMP compliance systems through the following activities:
  • Develops and implements processes, procedures, forms, work instructions and tools related to the implementation of compliance systems at the site.
  • Assesses compliance systems on ongoing basis to identify opportunities for process improvement.
  • Keeps abreast of regulatory compliance trends.


The Ideal Candidate:
  • The position of QS Specialist requires a third-level qualification (scientific/ engineering/ IT/ BIS discipline required)
  • A minimum of 3-5 years’ experience within the biological and/or pharmaceutical/ medical device industry
  • Knowledgeable of FDA/EMEA regulatory requirements
  • Demonstrated knowledge and application of industry regulations as they apply to systems including those of FDA, HPRA, EMEA and other authorities
  • Experience of managing project groups or leading teams
  • Skilled in the use of problem solving tools/techniques
    Experience with systems such as Trackwise and electronic documentation management systems will be a distinct advantage
  • Customer focus is critical
  • Builds strong productive relationships
  • Demonstrates ability to work with teams and individuals
  • Asserts personal ideas and opinions using persuasion to influence others
  • Seeks opportunities to grow and develop professionally
  • Uses best practices to improve business operations
  • Holds oneself accountable for compliant and flawless execution
  • Effectively manages and adapts to change
  • Demonstrates the courage to stand alone on ideas and opinions that differ from others
  • Listens effectively and remains open to other’s ideas.
  • Works effectively with people that have diverse styles, talents and ideas
  • Maintains the highest standards of ethical behaviour
  • Attention to detail and strong administrative skills


For further information on this Quality Systems Specialist in Cork please contact Orla on 086 0449473 / talent@hero.ie

Check out all our open jobs on our HERO Recruitment website – 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 
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“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"

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

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