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Vacancy Details

Quality

Principal Quality Specialist Cork - Cork - 90465

Contract Type: Permanent
Sector:
Location: Cork
Date: 21/01/2019
Job Reference: 90465
Contact Name: Orla Crowley - Healy
Contact Email: talent@hero.ie

Job Description

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

Principal Quality Specialist Cork

Our client, a pharmaceutical device company in Cork are currently looking to recruit a Principal Quality Specialist for their site.

Description
  • The Principal Quality Specialist will provide Quality oversight, support and expertise to GMP related activities and Quality Systems across the site and in meeting the Manufacturing Division (MMD) Priorities of: Compliance, Supply, Strategy and Profit Plan.
  • This role requires the delivery of a robust Quality Management System to support a flexible, collaborative, multi-skilled teamwork environment. The Principal Quality Specialist will have proven capability in development of Quality Systems across cross functional teams to deliver process improvement.
  • The team working style is one of collaboration, coaching and facilitation to ensure the success of the site. The Principal Quality Specialist is accountable for the Quality Systems within the site or where the role resides in the IPT will provide support to Operational Quality across site.

Primary activities/responsibilities:
  • Provides to the site and network, expertise in Quality Systems and/or Operational Quality, including the following i.e. Deviation/NOE/LIR coaching; GCM coaching; environment monitoring programs; sterile assurance; customer compliant investigations; etc.
  • Uses knowledge to improve Quality Systems and/or Operational Quality; solve complex problems, provide continuous improvement and execute tasks.
  • Coordinates the work of others within the team and in the site
  • Acts as a resource to colleagues with less experience in Quality Systems and/or Operational Quality
  • Leads project teams.
  • Coaches and guides colleagues within the site and also in the network.
  • Understands and applies regulatory / compliance requirements to their role together with remaining current on upcoming regulatory and compliance changes
  • Interprets customer needs, assesses requirements and identifies solutions to non-standard requests.
  • Makes decisions within guidelines and policies which impact Product Quality, Projects and Quality Systems.
  • Liaises with Corporate Quality to ensure alignment on actions related to Quality Systems and/or Operational Quality at the site.
  • Coordination and/or participation in inspections of Site by Divisional / Regulatory Bodies / third parties together with follow up actions where applicable.
  • Ensure supply of high quality product through implementation and oversight of the Quality Management System for the site.
  • Works with other sites to aid them and ensure alignment and best practices adopted for Quality System related topics and/or Operational Quality.
  • Champions Permanent Inspection Readiness (PIR) and Quality and Compliance Excellence (QCE) programs.
  • Ensure the highest Quality, Compliance and Safety standards.
  • The Principal Quality Specialist will participate and comply with the MMD
  • Quality Management System (QMS) requirements, including ownership.
  • Responsible for driving a culture of Continuous Improvement by deploying Six Sigma tools within the IPT
  • The Principal Quality Specialist will have proven capability in development of Quality Systems across cross functional teams to deliver process improvement. Model the Leadership behaviours and understand the MPS principles to drive a culture of continuous improvement building a High Performance Organisation.

Qualifications
  • At least 5 years' experience in the Pharmaceutical industry or a similar operating environment which includes a minimum of 2 years' experience in a Quality function.
  • Experience as QMS Sub System Owner as required for the Principal Quality Specialist role
  • SME in at least 4 QMSs as required for the Principal Quality Specialist role
  • Degree (in Science).
  • Green belt or suitable alternative.
  • Certified Auditor.
  • Demonstrated change management skills (CEM) with continuous improvement.
  • Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g. Quality, Science etc).
  • Quality Assurance SME knowledge from both operational and educational experience, is required
  • Demonstrated expertise in Quality Management Systems.
  • Demonstrated use of Leadership Behaviours
  • Knowledge and experience in interpreting current regulatory requirements and providing independent support to the site.
  • Demonstrated ability to work independently and fully realize improvement initiatives with minimal guidance.
  • Demonstrated ability to co-ordinate the work of others, as well as leading project teams.
  • Demonstrated ability to drive the completion of tasks.
  • Proven track record of providing independent Quality expertise to the site.
  • Demonstrated delivery of SME knowledge above site.
  • Demonstrated successes in a team environment, such as project teams, Six Sigma team, Tier 4s etc.
  • Advanced PC skills such as Excel, Word, PowerPoint.
  • Stakeholder management of multiple decision makers, auditors, cross functional teams by demonstrating the ability to maintain and strengthen trust relationships with people on all levels.
  • Proven decision making capability with full accountability and responsibility.
  • Demonstrated coaching skills
  • Demonstrated ability to clarify, communicate and solve complex problems.

For further information on this Quality Engineer II 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



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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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“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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