Qualified Person

  • Reference: CJ45969
  • Job Type: Permanent
  • Location: Munster, Waterford
  • Category: Engineering, Technical & Manufacturing

Role Purpose:

 

  • To release all bulk product and packaged product to market based on their Marketing and Manufacturing Authorisations and ensure all such relevant activities comply with all GMP and Regulatory requirements.
  • The purpose of controlling batch release is notably to ensure that the batch has been manufactured and checked in accordance with the requirements of its Manufacturing Authorisation Holder (MAH) as per the Technical Terms of Supply (TTS) and the Quality Agreements with the Local Operating Companies (LOCs).

Role Responsibilities:

Impact of role on business objectives:

  • On time release of medicinal and Medical device products to the market place to ensure customer satisfaction and reduced Inventory.
  • Ensure there is an effective problem-solving system in place to prevent recurrence of issues and therefore reduce waste.
  • Be the focal point of problem solving within the Value Streams when the situation demands it to ensure on-time resolution of issues to support batch release.
  • Understand all Quality systems and ensure that product is made to appropriate GMP standards.

Environmental Health & Safety (EHS) Responsibilities:

  • Perform duties in a compliant manner and behave in accordance with site SOP’s, EHS standards and guidelines and relevant legal requirements.
  • Read and understand Standard Operation Procedures applicable to role.
  • Report all accidents, incidents and any EHS issues using the appropriate process /system to your line manager or, if required, the Occupational Health Advisor.
  • Maintain work area in an inspection ready state and clean as you go to maintain good safe housekeeping standards.

 

Quality Responsibilities:

  • Site Qualified Person responsible for the release of medicinal product to markets.
  • Perform duties in a compliant manner and behave in accordance with our Quality Management System requirements.
  • Participate fully in our site’s quality initiatives and ensure that all relevant quality standards are adhered to.
  • Maintain GMP standards where appropriate.
  • Read and understand relevant SOP’s and Global Quality applicable to role.
  • Attend training and complete assessments as required.
  • Ensure Quality and GMP are at the forefront of changes proposed.
  • Deep understanding of regulations and ability to translate into compliant effective processes.
  • Experience of Change management and understanding of change control process.
  • Communication skills across site and organization.
  • Understanding of appropriate directives, standards and QMS systems relating to the manufacture and supply of medicinal products.

People Management Responsibilities:

  • Manage a team of approximately 4.
  • Excellent communication/interpersonal skills with a strong affiliation with customer support.
  • Work within a value/product stream environment.
  • Assist all Quality and Manufacturing functions in preparation for, and during external agency audits and internal audits.

 

Problem Solving:

  • Ability to think strategically and use sound judgment.
  • A champion of change to improve systems and processes.
  • Play a key role during investigations into significant incidents that have resulted in non-conforming products or compliance failures.
  • Demonstrated ability to effectively plan work and to manage projects.
  • Ensure effective problem-solving system is used to prevent recurrence of issues.
  • Be the focal point of problem solving within the Value Streams when the situation demands it.

Skills Required:

Basic Experience:

  • 5 years’ experience in a pharmaceutical/ healthcare company


Preferred Experience

 

  • Understanding of appropriate directives, standards, policies and guidelines and ability to implement appropriately, e.g.:
    • Directive 2003/94/EC
    • QMS
    • EU GMP
    • cGMP
    • Understanding of relevant regulatory requirements for all markets.
    • Understanding of quality systems for OTC.
    • Knowledge of all products and manufacturing processes for OTC.

Expected level of application of Knowledge

 

  • High level of knowledge required to understand the production processes and all Quality systems on site and to ensure they are appropriately used.
  • People management skills essential to lead a group of educated, skilled professionals

 

 

Desired Skills:

 

  • Be a flexible thinker
  • Supporting and aiding in the development of others
  • Have a strong interest in continuous improvement
  • Has to ability to enable & drive change
  • Be customer driven
  • Building Relationships
  • Must have strong interpersonal & communication skills

 

For a confidential discussion and more information on the role, please contact Eloísa Ruiz on 021 4911066 or email eloisa.ruiz@collinsmcnicholas.ie

For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie

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Eloísa Ruiz

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  • Eloísa Ruiz
  • Recruitment Consultant
  • 021 4809 118
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