Quality Assurance Specialist
|Contact Name:||Larry O’Leary|
Our client, a pharmaceutical company based in Galway, now seeks a Quality Assurance Specialist who will provide Independent Quality Assurance Support to the Operations Analytical laboratory. This hire wil ensure that raw materials, finished products, non-routine and stability testing is carried out in accordance with cGLP, cGMP both in company laboratories and at the contract laboratories.
The successful candidate will this hire will provide quality assurance support and direction to the analytical laboratory responsible for the testing and release of all drug combination products and raw materials used on the site.
This hire will maintain, develops and implements laboratory methodologies, systems and practices. Provide independent guidance to the analytical lab while ensuring compliance to procedure and cGMP requirements.
Responsibilities for Quality Assurance Specialist:.
Provide support and guidance in the areas of cGMP, Compliance, Regulatory, and Technical Investigation.
Working with the cross functional groups including product release, supply chain planning, shipping and distribution groups.
Preparation and compilation of Annual Product review on pharmaceutical products.
Schedule and Complete laboratory assessments.
Provide the independent review of NCEP’s and eCAPA.
Review and approval of equipment/ software testing method validation.
Requirements for Quality Assurance Specialist:
Honours Bachelor’s Degree in Science, i.e. Chemistry, Microbiology, Biochemistry, Biomedical, etc.
3+ years’ experience in Quality Assurance role in pharmaceutical or biotechnology industry is essential.
Excellent written and verbal communication skills.
Experience working with cross functional team environment.
Detailed knowledge of applicable regulatory requirements in cGLP, cGMP environment.
Experience is LIMS/SAP/Empower is desirable.
Good interpersonal and effective communication skills.
Strong organisational skills.
Please phone Larry on 01-2302400 / email@example.com
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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