Role Summary:

  • A new vacancy has arisen for a Quality Systems Specialist to join our client’s Quality Systems Team based at their busy biopharmaceutical facility in Co. Waterford.
  • The Quality Systems Specialist will ensure that effective quality systems are implemented meeting industry standards and all cGMP requirements.
  • The successful candidate will report to the Quality Systems Team Leader and support the Manufacturing areas and all support departments.
  • Interface with other Sites within the company network, as appropriate.

Core Duties and Responsibilities:

 

  • Ensure all appropriate Quality Systems are in place for the site meeting cGMP, Corporate Standards and industry best practise.
  • Perform critical/constructive review of procedures on site.
  • Identify Improvements and Lead Projects to make step change improvements to site quality systems.
  • Actively contribute to continuous improvement initiatives at the site.
  • Conduct all activities in a safe manner and report all safety issues and/or concerns.
  • Attends team meetings, regular 1:1’s, support owns goals and team goals and actively manages own performance development.
  • Define, manage and maintain key metrics for Site Quality Systems ensuring site visibility, strong internal customer satisfaction and trending to support continuous improvement activities.
  • Manage and support Quality Systems on Site as appropriate and/or other electronic quality tools.
  • Co-ordinate all Complaints from customers and other company sites ensuring they are appropriately logged, investigated, reported and trended ensuring collaboration with Regulatory and QP function.
  • Manage and continuously improve the Site Vendor Program incorporating Auditing, Complaint management, Quality Technical Agreement, Supplier File and Risk assessment where appropriate.
  • Manage, direct and support the Site Self Inspection Program (Internal Audit & Walkthrough Program)
  • Manage and improve the Site audit Readiness Program with cross functional ownership, effectively leading all external regulatory and corporate audits at the Co. Waterford site.
  • Lead and direct change management on the site continuously gaining feedback for improvement.
  • Supporting and providing appropriate information to support Product Performance Reviews (PPR)
  • Ensure compliance to cGMP at all times.

Minimum Qualifications and Experience:

  • Third level qualification (degree in science or related discipline)
  • Minimum of 2/3 years’ experience in a similar role Pharmaceutical or sterile Manufacturing experience would be an advantage.
  • Very good knowledge of cGMP in a regulated environment.
  • Excellent accuracy and attention to detail.
  • Strong Planning/Organising skills.
  • Proven and effective Project Management skills.
  • Customer Focus Driven with excellent interpersonal skills.
  • Excellent communicator with Good Presentation skills.
  • Working knowledge of computer systems.
  • Personal development and goal management skills.
  • Flexible and adaptable- comfortable and open to change.
  • Works well across all levels of the organisation, multi-site and multi-national environment.
  • Works on own initiative in a Self-Directed manner with minimal supervision.
  • Highly motivated and focuses on achieving results.
  • Takes personal responsibility for own development and actions.

Please note, we do not require agency assistance with this role.


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Role Details:

Job Title: Quality Systems Specialist
Location: Waterford
Type: Contract
Date: April, 2024
Image of recruitment specialist

Discuss with:

Ruth Holland
recruitment@prochem.ie
Recruitment Specialist
on +353 56 779 0100
Share:

Role Details:

Job Title: Quality Systems Specialist
Location: Waterford
Type: Contract
Date: April, 2024
Image of recruitment specialist

Discuss with:

Ruth Holland

recruitment@prochem.ie

Recruitment Specialist

on +353 56 779 0100

Share:

Role Summary:

  • A new vacancy has arisen for a Quality Systems Specialist to join our client’s Quality Systems Team based at their busy biopharmaceutical facility in Co. Waterford.
  • The Quality Systems Specialist will ensure that effective quality systems are implemented meeting industry standards and all cGMP requirements.
  • The successful candidate will report to the Quality Systems Team Leader and support the Manufacturing areas and all support departments.
  • Interface with other Sites within the company network, as appropriate.

Core Duties and Responsibilities:

 

  • Ensure all appropriate Quality Systems are in place for the site meeting cGMP, Corporate Standards and industry best practise.
  • Perform critical/constructive review of procedures on site.
  • Identify Improvements and Lead Projects to make step change improvements to site quality systems.
  • Actively contribute to continuous improvement initiatives at the site.
  • Conduct all activities in a safe manner and report all safety issues and/or concerns.
  • Attends team meetings, regular 1:1’s, support owns goals and team goals and actively manages own performance development.
  • Define, manage and maintain key metrics for Site Quality Systems ensuring site visibility, strong internal customer satisfaction and trending to support continuous improvement activities.
  • Manage and support Quality Systems on Site as appropriate and/or other electronic quality tools.
  • Co-ordinate all Complaints from customers and other company sites ensuring they are appropriately logged, investigated, reported and trended ensuring collaboration with Regulatory and QP function.
  • Manage and continuously improve the Site Vendor Program incorporating Auditing, Complaint management, Quality Technical Agreement, Supplier File and Risk assessment where appropriate.
  • Manage, direct and support the Site Self Inspection Program (Internal Audit & Walkthrough Program)
  • Manage and improve the Site audit Readiness Program with cross functional ownership, effectively leading all external regulatory and corporate audits at the Co. Waterford site.
  • Lead and direct change management on the site continuously gaining feedback for improvement.
  • Supporting and providing appropriate information to support Product Performance Reviews (PPR)
  • Ensure compliance to cGMP at all times.

Minimum Qualifications and Experience:

  • Third level qualification (degree in science or related discipline)
  • Minimum of 2/3 years’ experience in a similar role Pharmaceutical or sterile Manufacturing experience would be an advantage.
  • Very good knowledge of cGMP in a regulated environment.
  • Excellent accuracy and attention to detail.
  • Strong Planning/Organising skills.
  • Proven and effective Project Management skills.
  • Customer Focus Driven with excellent interpersonal skills.
  • Excellent communicator with Good Presentation skills.
  • Working knowledge of computer systems.
  • Personal development and goal management skills.
  • Flexible and adaptable- comfortable and open to change.
  • Works well across all levels of the organisation, multi-site and multi-national environment.
  • Works on own initiative in a Self-Directed manner with minimal supervision.
  • Highly motivated and focuses on achieving results.
  • Takes personal responsibility for own development and actions.

Please note, we do not require agency assistance with this role.

Image of recruitment specialist

Discuss with:

Ruth Holland
recruitment@prochem.ie
Recruitment Specialist
on +353 56 779 0100
Share:

Apply Now

"*" indicates required fields

Full Name*
Accepted file types: pdf, docx, odt, doc, txt, Max. file size: 32 MB.
Accepted file types: pdf, docx, odt, doc, txt, Max. file size: 32 MB.
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