Browse by job sector

Quality Specialist

  1. NI & Ireland
Dublin
  1. Contract
Competitive
  1. Compliance / Quality Assurance
17-03-2020
24591- ML

This vacancy has now expired

 

Do you relish the opportunity to work with a leading Irish based Biologics manufacturer?  If yes, then this is the assignment for you!


Our biotech client based in Dublin City Centre is currently seeking the expertise of Quality Specialist on a 12 month contract.


Essential Duties and Responsibilities for this Quality Specialist role include, but are not limited to, the following:
  • Initiating, writing and managing the complaint investigation to completion.
  • Serve as point of contact for commercial product complaints and post market product vigilant monitoring processes.
  • Receive, initiate, investigate and conclude product complaint investigations using the current product complaints management mailbox and software.
  • Coordinate all aspects of investigation through to closure and/or provide oversight for complaint handling process.
  • Apply departmental procedures to assess product complaints' impact on patient safety and product quality compliance.
  • Assess product complaints and determine if escalation is required due to potential regulatory notification requirements.
  • Interface and collaborate with various departments including the OpUs, External Supply, Quality Assurance, Regulatory, Development, Safety/Pharmacovigilance, etc and the regional organisation. Interface with external stakeholders such as  CMO, Call Centres and vendors/contractors on product complaint issues.
  • Assure that all product complaints are investigated to the appropriate level within the required timeline.
  • Send customer response letters where required.
  • Support the departmental complaint management process through attendance of meetings to ensure on time closure of complaints.
  • Support line manager to meet business needs.
Desirable Experience:
  • Experience in Quality Assurance or a GMP related field within Medical device, biotechnology or pharmaceutical manufacturing, or equivalent.
  • Working knowledge of cGMPs and other regulatory requirements governing combination drugs and device products.
  • Knowledge of EU/ FDA cGMP requirements pertaining to drug/device product complaints reporting and investigation.
  • Desirable experiences: combination working experiences in product complaints handling, deviation management, CAPAs, quality compliance investigations, risk management, and cGMP audits.
  • Good understanding of the manufacture of combination products and the linkage to customer complaints.
  • Strong attention to detail, good organizational skills and well-structured.
  • Has a systematic way of working, prioritizing tasks based on risk - seeking effective solutions within the complexity that surrounds product complaints.
  • Excellent troubleshooting and problem-solving skills.
  • Skill in writing investigation summaries or reports and complaint responses.
  • Independent, organized and able to schedule work without supervision to meet schedule deadlines.
  • Ability to work independently as well be an effective team member and leader.
  • Approachable and possess the ability to forge solid working relationships with colleagues across all functions, its partners and contractors
  • Positive and Professional attitudes towards work and colleagues


The candidate must have the rights to work in the location stated in the job advert.

Please note, Quanta Consultancy Services does not sponsor Visa applications.

To view Quanta's privacy policy, please visit our website
Save as a job alert
List #1

Similar Jobs

Warehouse Facilities PMO Consultant

Salary

Competitive

Location

North Carolina

Salary

Competitive

Sector

Compliance / Quality Assurance

Job type

Contract

Location

East Coast

Description

PMO Consultant – Warehouse & Facilities Focused  - Pharmaceuticals - North Carolina  Our client, a global Pharmaceutical manufacturing organization are looking for a talented PMO

Reference

34128

Expiry Date

01/01/0001

Mark Chaumeton

Author

Mark Chaumeton
Mark Chaumeton

Author

Mark Chaumeton
Read more
Read more
Quality Control PMO Consultant

Salary

Competitive

Location

North Carolina

Salary

Competitive

Sector

Compliance / Quality Assurance

Job type

Contract

Location

East Coast

Description

PMO Consultant - QC Focused - Pharmaceuticals - North Carolina - 12-Month Contract  Our client, a global Pharmaceutical manufacturing organization are looking for a talented PMO Consultant to

Reference

34127

Expiry Date

01/01/0001

Mark Chaumeton

Author

Mark Chaumeton
Mark Chaumeton

Author

Mark Chaumeton
Read more
Read more
Quality Control Analyst

Salary

Competitive

Location

County Dublin

Salary

Competitive

Sector

Life Sciences

Compliance / Quality Assurance

Job type

Contract

Location

Dublin

Description

QC Microbiology Analyst - Dublin - 12-Month Contract  Do you want to be part of one of the top 10 best companies to work for in Ireland? If so, this could be your chance! One of our global

Reference

33808

Expiry Date

01/01/0001

Tom Evans

Author

Tom Evans
Tom Evans

Author

Tom Evans
Read more
Read more

Insights

A Day in the Life of a Quality Assurance Specialist in the Pharmaceuticals World

A Day in the Life of a Quality Assurance Specialist in the Pharmaceuticals World

Read more

10/27/2023

Your next step as a Validation Engineer
Read more

07/20/2021

Why should I be open to being headhunted?
Read more

09/04/2020

VIEW ALL

Send us your CV

Our candidates are the cornerstone of our organisation and we are always looking to connect with new professionals who are seeking their next contract assignment or career opportunity.

Send your CV
Upload your CV