Connecting to LinkedIn...

Vacancy Details

Science Pharmaceutical and Food

Senior Qualified Person (QP) - Cork

Contract Type: Permanent
Location: Cork
Date: 1/08/2017
Job Reference: 88505

Job Description

Contact: Bimi Felix
Telephone: 091 730022

Senior Qualified Person
Our client a leading biotech company based in Cork is looking for a Senior QP to join their team. For more than 25 years this company has been a global leader in the field of biomedicines
The QP is responsible for controlling batch release as per Annex 16 to the EU Guide to Good Manufacturing Practice in the Cork facility that is now operational producing biomedicines for both the treatment of immune related diseases and new and innovative cancer treatments. If you are looking to join a dynamic team with excellent career progressions then read below:

Key Responsibilities of QP role:
  • Responsible for certifying DSP batches prior to release to filling site.
  • Ensure that the batch and it's manufacture comply with GDP; GMP; Marketing authorization; IMPD; Import License etc, depending on the product requirements
  • Maintain oversight of deviations and change controls and ensures that any issues which have a regulatory impact are notified to health authorities and mitigated as required
  • Ensures that all necessary tests and checks have been performed prior to batch release.
  • Ensures that all necessary production and quality control documentation has been completed and endorsed by authorized staff
  • Attends QMR review meetings to ensure that the quality system continues to function effectively and that improvement/remediation actions are taken as required
  • Maintains knowledge and understanding of quality oversight for services and operations which are outsourced to CMO's / contract test labs
  • Maintain knowledge and experience up-to-date. If a new product type is introduced the QP should ensure that they have gained the relevant knowledge and experience necessary to complete QP duties.
  • Maintains oversight of issues/escalations related to batches post release ensuring that appropriate actions are taken as required.
  • Supports QA colleagues with product quality / license impact assessment for deviations

Education, Experience and Skills
  • MSc or Higher Diploma in Pharmaceutical Sciences/ Pharmaceutical Manufacturing Technology which fulfils the QP educational requirements.
  • Industry experience within a QP role within a regulated biologics or pharma industry.
  • Knowledgeable of FDA/EMA regulatory requirements
  • Excellent social and communication skills
  • Self-driven and keeps up to date with regulatory, technical developments within the industry.
  • Acute attention to detail
  • Excellent team player with strong customer focus

For further information on this Senior Qualified Person (QP) role in Cork please contact Bimi Felix on 091730022 /
Check out all our open jobs on our HERO Recruitment website -

Please Note: HERO Recruitment will not forward your details to any company without your prior approval

Share this Job

Our Clients

With a reputation across three decades in the making, HERO Recruitment continues to impress our clients and candidates with our passion and dedication to our craft.

See More

What people say

Our strong reputation for quality placements in key roles has earned us the status of agency of choice. HERO Recruitment’s commitment to superior service is what sets us apart from our competitors and has rewarded us with many exclusive and semi-exclusive client and candidate relationships.  Here is what our clients and candidates say about us…

See More

“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

“Merit Medical have partnered with Hero for the past 10 years. During this time we have grown our employee numbers to 630 employees. Our experience of working with HERO is that they have a personal client focused approach, they know the market and they can deliver on the candidates.  The medical device market is competitive and our company success is dependent on the quality of our people, we want the best there is in the market so we can grow and in turn offer development opportunities to our people. 

Mary Collins,
Senior Director, Human Resources Europe
Merit Medical

“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

“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