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Vacancy Details

Quality

QA Specialist - Cork

Contract Type: Contract
Sector:
Location: Cork
Date: 1/09/2017
Job Reference: 88558

Job Description

Contact: Bimi Felix
Email: bimi@hero.ie
Telephone: 091730022

QA Specialist
Our client, a medical device company in Cork are currently looking to recruit a QA Specialist for their site on a contract basis.

Position Description and Responsibilities
  • This position is responsible for carrying out tasks and projects related to managing compliance activities during qualification and validation related to the company's projects as required by Good Manufacturing Practice (GMP).
  • These activities include review and approval of change controls, non-conformance investigations, and protocols. Primary Tasks and Responsibilities
  • Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met following the company's Standard of Leadership behaviour model.
  • Partners with other Departments to ensure that compliance systems are implemented in an efficient manner.

Supports the management of GMP compliance systems through the following activities:
  • Assesses compliance systems on ongoing basis to identify opportunities for process improvement.
  • Carries out tasks related to the administration of project and site non-conformance management systems.
  • Reviews and/or approves non-conformance investigations and their associated documentation.
  • Manages entry of non-conformance records into the appropriate electronic system.
  • Tracks investigations from the initiation through closure processes and advises relevant personnel on the status of investigations and associated CAPA and commitments, as appropriate.
  • Coordinates investigation activities to ensure root causes are identified and that corrective actions are appropriate.
  • Approves closure of non-conformance investigations on completion of the investigation and associated corrective actions.
  • Carries out tasks related to the management of project and site change control systems:
  • Reviews and/or approves change control requests, implementation actions, and request closures.
  • Manages entry of change control records into the appropriate electronic system.
  • Tracks records from the initiation through closure processes and advises relevant

Non-Technical Skills and Additional Details
  • Influence and facilitate the work of other departments and functions in achieving and maintaining state of GMP compliance.
  • Establish effective partnerships with other individuals, departments and GBSC affiliates so that compliance activities are well understood and coordinated.
  • Actively promote improvement programmes towards continuous compliance during qualification and validation.
  • Actively promote and apply strategic thinking to compliance activities
  • Facilitates the work of other departments and functions in achieving and maintaining state of GMP compliance during qualification and validation activities.
  • Establishes effective partnerships with other individuals and departments so that quality systems and compliance activities are well understood and executed to a high standard.
  • Interface with all site departments, Operations and Maintenance.
  • Contact with Quality Assurance Manager for management of qualification and compliance activity.
  • Directors and managers of other departments for coordination of qualification document reviews and approvals, including associated change controls, non-conformance investigation, and completion of commitments.

Qualifications and Experience
Essential
  • Bachelor's Degree in a scientific/technical discipline required
  • A minimum of 2 years' experience in a quality, validation or compliance role within the biological and/or pharmaceutical industry.
  • Demonstrated knowledge and application of industry regulations as they apply to qualification and validation, including those of FDA, IMB, EMEA and other authorities.
  • Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.

Desirable
  • Experience in statistical sampling plan development.
  • Experience in a biopharmaceutical or pharmaceutical plant start-up.

For further information on this role in Cork please contact Bimi Felix on 091730022 /bimi@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




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

“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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“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

“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
More

Clients we are proud to work with

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