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Vacancy Details

Quality

Qualified Person / QP / Quality Manager - Mayo - 98857

Contract Type: Permanent
Sector:
Location: Mayo
Date: 21/01/2019
Job Reference: 98857
Contact Name: Bimi Felix
Contact Email: bimi@hero.ie

Job Description

Contact: Bimi Felix
Email: recruit@hero.ie
Telephone: 086 8395533

QA Manager/QP

Our client, a pharma company in Mayo is currently looking to recruit an QA Manager/QP for their site.

Description:
The Quality Manager will hold responsibility for QA activities in support of the process through the Product Release Function. The role will provide support to the QA/QP Associate Director in addition to the Business Unit Leader in achieving the required goals and objectives; meeting customer requirements and the necessary regulatory requirements as lay down by the FDA, EU and regional Ministries of Health as relevant. The Quality Manager will assist the Associate Director in the management of key quality system elements including:
  • Act in the capacity of a Qualified Person in accordance with Annex 16, EudraLex Volume 4 and Directive 2001/83/EC to support disposition of Products
  • Manages the batch disposition process to ensure timely release of products
  • Ensures the batch disposition process maintains compliance with site practices and regulatory requirements
  • Support the Non Conformance/ CAPA program
  • Support the Change Management program in the Business Unit
  • Be a SME for quality records and quality systems, ensuring consistency of records
  • Promote technical writing and quality awareness
  • Provide Quality support to site projects
  • Support the Self-Inspection program
  • Inspection Management (internal site preparation, pre-audit MOH requests, Response/ report compilation & issuance, Post audit commitment management)
  • Represent quality at daily and weekly cross functional meetings
  • Support the site quality plan and ensure plan execution
  • Coordinate compliance initiatives
  • Support the Site Quality Risk Management Program

Responsibility:
The QA Manager will have the authority to hire, promote and manage the performance of the product review department. The total staff to be supervised included three direct reports.

People
  • Maintain strong relationships with management and colleagues in the business units, support functions and the quality site and global functions.
  • Articulate the necessary quality requirements in a clear, concise and persuasive manner
  • • Manage and develop the Product Review Department %

Strategic
  • Quality project oversight
  • Identify and support the implementation of the action plans to eliminate re occurring issues within the Business Unit.
  • Identify areas to continuously enhance the performance of the Business Unit and support the implementation of key initiatives

Management
  • Develop and follow Leader’s standard work.
  • OPEX Tier meetings
  • Drive Quality Culture and Compliance improvement initiatives
  • Annual Product Review
  • ECR/ECO Approval through PAM
  • RCPS Focus on Reduction in Repeat and Human Error deviations
  • Co-Ordination of Business Unit Quality Defect Reports
  • Focus Site Quality and Plant of the Year (POY) metric achievement
  • QMS records Review and Approval
  • Validation documents, Project documents, Risk assessments, Master Records, SOP Review and Approval
  • Representing the Company at client and regulatory facing meetings
  • QP support regarding batch certification and approval of CofAs

Administration/Meetings
  • Attend all routine meetings as required.
  • 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
  • Co-ordinate the completion of process improvements initiatives in conjunction with the Business Unit Managers.
  • Support and ensure the Quality Management System is maintained to a high standard.
  • Administer LMS/CORAL.


Job Qualifications (Minimum Requirements):
Education and Experience
  • Bachelors degree in scientific discipline
  • Education requirements for Qualified Person eligibility
  • Minimum 5 years of relevant work experience in pharmaceutical or related industry
  • Experience in aseptic manufacturing and sterilisation processes is desirable

Essential Skills, Experience
  • Clear understanding of working within a regulated environment
  • Excellent communication skills
  • Ability to use sound judgment to make effective decisions within appropriate timeframes
  • Proven to be self-directed, self-motivated and ability to prioritise competing priorities
  • Relationship Building: Establishing excellent working relationships with all functions within the business unit and QA team.
  • Communication: excellent communication and presentations skills, both written and oral. Articulate the quality requirements in a clear, concise and persuasive manner.
  • Planning & Organising: excellent analytical skills. Ability to plan and schedule.
  • 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: - Drive, high energy, maturity, and ability to work under pressure and deliver results; get things done (an action-oriented approach); overcome obstacles.
  • Receptivity to feedback - Receptive to the ideas of others and welcome and accept constructive feedback, display humility where appropriate.
  • Have a people centred approach to their work whilst upholding the values and ethos
For further information on this QA Manager/QP role in Mayo please contact Bimi on 086 8395533 / recruit@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.

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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
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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,
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,
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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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