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Vacancy Details

Quality

Qualified Person - Cork

Contract Type: Permanent
Sector:
Location: Cork
Date: 3/10/2016
Job Reference: 85178

Job Description

Qualified Person

Our client a leading global pharmaceutical company requires an experience QP for a permanent role.

This position is responsible for carrying out tasks and projects related to management of Quality Assurance activities at JSCI as required by Good Manufacturing Practice (GMP). These activities include Material release, Change control, Event management, supplier qualification, and Annual product review and validation compliance activities. And also provide support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met.

Key Responsibilities:
  • Carries out tasks related to the administration of event management systems including Review & Approval of Event, Deviations, and Customer complaints.
  • Batch Record Review & material release to ensure compliance with GMP
  • Carries out tasks related to the management of batch records design and approval. Ensures that Batch Operating Instructions are compliant with filed descriptions.
  • Carries out tasks relating to the management of site change control systems.
  • Supports & GMP conducts GMP/ICH Q7 training as required.
  • Compiles Annual Product Reviews.
  • Supports all validation activities on site as described in the Site Validation Master Plan.
  • Approves and compiles where appropriate validation protocols and reports (analytical, cleaning, computer, process, equipment, etc.).
  • Supports system qualification and process validation activities.
  • Reviews and approves SOPs/work instructions/forms from other departments on behalf of Quality Assurance
  • Co-ordinates and assists in the preparation for regulatory and customer GMP inspections of the site.
  • Participates in the introduction of new process or modified process steps, as part of a New Product Introduction Team (NPI)
  • Perform GMP audits on-site and vendor facilities as required.
  • Carries out tasks related to the administration of site supplier approval process.
  • Adheres to and supports the company safety policy and safety programmers.
  • Engages in Site Credo initiatives
  • Performs QP certification of Sterile API batches (and related activities)
  • Contribute to innovative and viable products, services and/or solutions, adding value. Challenges the status quo and adapt to change, taking advantage of opportunities to have a positive impact.
  • Identifies and communicates meaningful risks, takes appropriate action and demonstrates an awareness of the highest standards of quality and compliance.
  • Take accountability for their performance and development alongside supporting talent acquisition and the development of others.
  • Leverages diverse perspectives, backgrounds and talent to generate effective ideas or solutions and engage in transparent and constructive conversations, contributing to high-performance teams.

Education, Experience and Skills:
  • Qualified Person (QP) qualification and at least 5 years QA/Validation experience.
  • Is Customer focused
  • Innovative and Excellent communication
  • Attention to detail with
  • Good problem solving skills
  • Results and performance driven
  • Adaptable and flexible
  • Experience of Sterile manufacture.
  • Decision making



For further information on this Qualified Person role in Cork please contact Cliona O?Malley on 091730022 / cliona@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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