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Vacancy Details

Quality

Quality Assurance Specialist - Mayo

Contract Type: Permanent
Sector:
Location: Mayo
Date: 29/01/2020
Job Reference: 107028
Contact Name: Clara Burke
Contact Email: science@hero.ie

Job Description

Quality Assurance Specialist
Our client a pharmaceutical company in Mayo is looking to hire a Quality Assurance Specialist for their site.

Summary
A QA Specialist will hold responsibility for QA activities in support of all aspects of commercial, clinical and development activities at the site. The specialist will assist Senior manager in the management of key quality system elements including:
  • Deviation management
  • Change Control Program,
  • Inspection Management: (Coordinate site GMP inspections; Internal site preparation; pre-audit MOH requests; Response/report compilation & issuance; Post audit commitment management);
  • Quality metrics & monthly quality system & Senior Management review meetings; (Meeting preparation and coordination of post meeting commitments
  • Manage regulatory standard/guidance revision assessments:
  • Coordinate the site quality plan and ensure plan execution:
  • Manage compliance initiatives program:
  • Management of site quality risk management program: (Management of the site QRM improvement plan. Attend risk assessment meetings)
The Specialist is accountable for their individual areas of responsibility within the quality system. The position holder must show the competence to drive forward the quality processes at the site and the skills to ensure that Compliance adds to the greater benefit of the facility. The Specialist must represent the quality function for routine commercial activities at the site ensuring quality compliance is upheld across all business units and supporting functions as deemed necessary. The position holder will provide the necessary guidance relating to quality activities in support of new product introductions and site strategic projects. In association with the Snr manager the QA Specialist 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.

Main Responsibilities
Strategic
  • Work with the Snr Manager on the delivery of the company quality plan and global regulatory requirements for the site
  • Assess quality implications of new regulatory guidance and implement necessary changes
  • Manage quality requirements for process changes & new product introductions as deemed necessary
  • Ensure effective recording, analysis and reporting of quality KPIs ensuring issues impacting quality performance are addressed and drive continuous improvement.
  • Demonstrate active support and involvement in successful progress of compliance initiatives to enhance the site quality program.
  • Represent the company in Ministries of Health inspections as required
Management
  • Provide quality input as required, providing information on day to day activities as a member of the site quality team.
  • Work with business unit representative and supporting functions to ensure site and global quality metrics are achieved and exceeded each month through the implementation of department process improvements and working with key site vendors to ensure high quality standards are implemented.
Administration/Meetings
  • Co-ordinate quality management system for area of responsibility and site overview
  • CORAL: Review and approval of assigned documentation as deemed necessary and the process quality agreements.
  • Coordinate site quality monthly meetings for assessment of quality system performance
  • Compile quality metrics for business units and support functions
  • Compile data and coordinate meeting requirements for the bi-annual senior management review meetings as per regulatory requirements
  • Coordinate the review of revisions to regulatory standards/guidance
  • Assist in the preparation and management of site MOH and customer inspections
  • Management of vendor audit program
  • Review and approval of Trackwise records and associated documentation
  • Complete assigned internal and external audits
  • Management of completion of interventions for media run schedule for the business units
  • Coordination of site residual monitoring program.
  • Attend all routine meetings as required or arrange an appropriate deputy. For example: Site Project meetings/EH&S Meetings, Tier Boards/OPEX meetings as assigned.
  • Ability to independently represent the quality function at project meetings and make sound decisions in support of project needs ensuring quality needs are understood and implemented
Education and Experience
  • Third level Science qualification
  • Proven track record in a quality discipline in the Pharma/Medical Device environment

For further information on this Quality Assurance Specialist role in Mayo please contact Clara Burke on 086 8168273 / science@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”. 


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

I am extremely grateful to Anne-Marie at HERO Recruitment for helping me land an opportunity in Ireland. She had a great deal of information regarding the job profile, was extremely prompt in arranging an interview and followed it up brilliantly. She was an excellent point of contact between the employer and me during the whole process. She has good knowledge about the process and was well aware of the timelines. I would recommend Anne-Marie, HERO Recruitment to anyone who is looking for opportunities in the country

Nikhil Pradeepkumar
Optical Engineer
Valeo Vision Systems
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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

I am extremely grateful to Anne-Marie at HERO Recruitment for helping me land an opportunity in Ireland. She had a great deal of information regarding the job profile, was extremely prompt in arranging an interview and followed it up brilliantly. She was an excellent point of contact between the employer and me during the whole process. She has good knowledge about the process and was well aware of the timelines. I would recommend Anne-Marie, HERO Recruitment to anyone who is looking for opportunities in the country

Nikhil Pradeepkumar
Optical Engineer
Valeo Vision Systems
More

Clients we are proud to work with

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