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Senior QA Auditor

Up to €60k | Ireland |  Quality Assurance and Supply Chain |  Permanent  | Ref:889902

The Role

Senior QA Auditor - CRO - Ireland - Up to €60k

 

The Company

Privately owned global CRO providing support to the Pharmaceutical, Biotechnology and Medical Devices sectors. Have offices in the UK, Ireland, Canada, Australia, Singapore and the USA and operate throughout Europe, North America, South America, India, China, Africa and Australasia.

  • Conduct clinical trials of all sizes with expertise in cell and gene therapies, orphan drugs, CNS and medical devices
  • Are a fast growing, dynamic company that offer invaluable experience, exceptional development and progression for employees
  • Competitive salary and benefits package

 

The Role

  • Perform tasks relevant to the assigned Quality & Compliance function including but not limited to
  • conducting internal and vendor audits, Regulatory/Sponsor inspection/audit defence, case management and CAPA management
  • Conduct departmental and staff training regarding quality system, Q&C tasks & processes, applicable standards, regulations; mentor new or developing Q&C staff as assigned, including providing constructive and effective feedback to trainees regarding skill capabilities during training.
  • Escalate quality and compliance issues to Q&C Line Management and relevant company functions as appropriate
  • Liaise with clients and operational persons including managers on quality aspects which may include attendance at meetings, oral presentations and audits.
  • Assist with business development activities, including the preparation of contracted audit cost proposals/contracts, and attend marketing presentation, when appropriate
  • Have a thorough knowledge of all relevant SOPs, and appropriate regulations and guidelines.
  • Understand key business drivers; uses this understanding to accomplish own work
  • Build knowledge of the company, processes and customers.
  • Assume additional responsibilities, which are directed by the Q&C Manager or higher.
  • Travel (up to 35%) domestic and/or international, on occasion this may increase based on business needs.

 

You

  • Thorough knowledge of relevant GxP regulations and accreditation requirements as relevant, including but not limited to GCP, GMP, GDP, GVP, GLP, 21CRF Part 11, CAP, CLIA and any local regulations
  • Ability to review and evaluate clinical data/records/systems/processes
  • Thorough knowledge and experience in performing and leading Root Cause Analysis.
  • Ability to manage complex issues and related CAPAs, including leading large cross functional teams, task prioritization, and project management as needed.
  • Demonstrated coaching, mentoring & training skills, including the ability to give constructive feedback
  • Highly developed problem solving skills, and the ability to resolve difficult situations.
  • Well-developed interpersonal and communication skills (oral and written)

 

What should you do next?

This Senior Auditor role is one not to be missed; it encompasses the opportunity to work for a well- established and reputable company. To discuss further, please submit your current CV.

Unless otherwise stated, if applying for a job within the European Union, you must ensure that you are already authorised to work there.

Carrot Pharma Recruitment Ltd acts as an Employment Business and an Employment Agency on behalf of our client in recruitment for this role.

Consultant

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Nadya Libecans

Which team and area do you work/specialise in?

I work on the Drug Development team specialising in Quality (QA) and Supply Chain roles within the pharmaceutical, medical devices and consumer healthcare markets.

What are some of the typical roles you cover?

I cover all levels from Administration to Director level within QA, QC, Supply Chain, Procurement and Logistics.

What are the hot issues in your sector currently?

For both Quality and Supply Chain, Brexit is a huge topic at the moment. Clients and candidates I work with have been working extensively to organise contingency strategies to minimise the effects to cost of manufacture and speed of product delivery.

What’s makes you #DistinctlyDifferent?

I believe knowledge is power and I strive to learn as much about people and the industry as possible to build lasting relationships and produce the best results for candidates and clients. 

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