QA Specialist

Dublin  ‐ Onsite
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Keywords

Description

A Biopharmaceutical client has a requirement for a QA Specialist with previous experience in the Pharmaceutical or Biopharmaceutical sector

This client has been a market leader in biotechnology since 1980, where the organisation focuses on the discovery, development, manufacturing, and delivering of innovative human therapeutics.
The organisation pioneered the development of DNA and molecular products, and launched the biotechnology industry's first blockbuster medicines. Today, as a Fortune 500 company serving millions of patients, it continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness.

To be considered for this position you will have experience within the pharmaceutical/Biotechnology arena. You will be required to perform all duties in accordance with Good Manufacturing Practices and company requirements.

Duties will include (but are not limited to):
- Quality walks of manufacturing area and manage actions
- Perform quality audits to ensure compliance with cGMPs
- Compile QC and manufacturing Batch records and reviews for compliance to CGMPs and product licenses
- Prepare monthly metrics
- Train new colleagues
- Champion safe working practices and safety initiatives within functional area.
- Prepare deviation reports for shipments as required
- Review and approve master Batch records
- Quality participation in root cause analysis
- Review and approval of Non conformances and CAPAs
- Quality representative in Non conformance triage using 5 Why or similar methodology
- Aseptic Manufacturing

Minimum Requirements:
Degree in science related discipline

Preferred Requirements:
- Relevant experience in a pharmaceutical/biotechnology Quality role
- Key competencies as follows:
- planning and organisation
- problem solving
- team work
- flexibility
- coaching and motivation
- knowledge and experience of Aseptic manufacturing
- good interpersonal skills
Start date
ASAP
Duration
12 months
From
Quanta Consultancy Services
Published at
10.04.2013
Project ID:
518786
Contract type
Freelance
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