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Senior QA Specialist

Employer
i-Pharm Consulting
Location
Republic of Ireland, Dublin
Salary
£361.44 - £415.66 per day
Start date
6 Nov 2019
Closing date
20 Nov 2019

View more

Discipline
Quality, QA / QC
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)

Job Details

At MSD Dublin Biotech we are recruiting an Inspection Readiness, Senior Specialist (QA) contract position to join our existing Quality team on site.

Position responsibilities as follows:

  • Support the launch and implementation of the Inspection Readiness Program on-site.
  • Support the Site Internal Audit Program to align with start-up activities
  • Support Compliance direction for the site by ensuring adherence to divisional policies and guidelines as well as applicable Regulatory Requirements.
  • Lead proactive evaluation of site compliance against emerging regulatory trends.
  • Ensure that quality issues are identified, addressed and resolved before activities commences.
  • Be an advocate of continuous improvement in the Quality Management Systems.
  • Initiate and maintain Quality related metrics related to the Site Inspection Readiness program, ensuring effective communication and follow up of same.
  • Lead and perform internal audits (facility, system and walkthrough) in addition to supporting management of the internal audit schedule at the site.
  • Effectively communicate audit/inspection results to stakeholders and site leaders.
  • Evaluate root cause analysis, CAPA responses, monitor CAPA completion, and verify CAPA effectiveness for audits & inspections for complete remediation.
  • Support the preparation and hosting Health Authority inspections and Divisional GMP Audits.
  • Generate and report metrics / trends for program adherence to requirements and effectiveness.

Qualifications and Experience

General

This role requires a seasoned QA Senior Specialist with a minimum of 8 years' experience in a similar role in the Pharmaceutical or Biological industry.

A self-starter and results-focused, the successful candidate will have strong contemporary knowledge of relevant GMPs, regulations and current industry trends.

Technical

Must have at least 3 years experience in delivering Inspection Readiness Programs and Internal Audit programs in a regulated environment.

People

  • The motivation to be an inspiring member of a high performing team.
  • Communication, decision making, people influencing and project management skills will be important.
  • Strong contemporary knowledge of relevant cGMPs, regulations and current industry trends.
  • GMP Inspection Readiness & Audit experience in the Pharmaceutical industry
  • Problem-solving / critical thinking - ability to understand connections between different technical/quality system areas and recognize potential compliance issues
  • The desire to continuously learn, improve and develop

Education

Bachelor's degree (or higher) in Chemistry, Biology, Microbiology, Engineering or in a relevant discipline, the successful candidate will also ideally have a proven track record in delivering excellence. The candidate will also show ambition and drive to develop and advance their career within MSD.

Company

i-Pharm Consulting provides Talent Solutions for the global Life Sciences sector.

We are an award-winning international life sciences recruitment company with offices in London, Munich, Frankfurt, Sydney, New York, Charlotte, and Los Angeles. In a highly competitive marketplace, we connect top talent with the very best opportunities.

Since 2008, i-Pharm’s independent, expert, and ethical approach to procuring talent has helped power the pioneering progress made by Pharmaceutical, Biotech and MedTech companies around the world. 

With offices across 3 continents, we have teams servicing the major global life science hubs. We combine local knowledge, with a global network of contacts that allows us to bring together talent and opportunity when it matters most.

For candidates, we become “career partners”. We know them as people, not CVs, learning about their aims, motivations and personal situation. We build open dialogue, provide honest advice and offer ongoing support, whether or not we’re currently working with them. ​

As a result, we have supported many specialists in this focused field throughout their careers, helping them plan their path through life sciences by identifying the right roles for them, not just any roles to suit us.

We change the lives and trajectory of our candidates' careers by offering incredible opportunities with the best clients in the sector.

 

Company info
Website
Telephone
+44 (0) 20 3189 2299
Location
52 Bedford Row
London
England
WC1R 4LR
United Kingdom

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