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Senior Quality Assurance Specialist NPI

1 week ago

Dublin, Dublin City, Ireland Life Science Recruitment Full time
Company Overview:
We are a leading life science recruitment agency based in Dublin. Our mission is to provide high-quality services to our clients and candidates.

Job Description:
We are currently recruiting for an exciting opportunity with a prestigious pharmaceutical organization.

Duties:

We are looking for a Senior Associate Quality Control NPI who will be responsible for planning and performing analyses with great efficiency and accuracy.

Plan and perform multiple, complex routine/non-routine methods and procedures and a large variety of assays.
Evaluate and report analytical data.
Troubleshoot problems and communicate with stakeholders.
Initiate and/or implement changes in controlled documents.
May train others as necessary.
Participate in audits, initiatives, and projects that may be departmental or organizational in scope.
Write protocols and perform assay validation and equipment qualification/verification.
Introduce new techniques to the lab, including method transfers, reports, validations, and protocols.
May contribute to regulatory filings.
May conduct lab investigations as necessary.
Evaluate lab practices for compliance on a continuous basis.
Approve lab results.
May represent the department/organization on various teams.
May interact with outside resources.
Create APPX data files and randomisation memo to facilitate data analysis.
LIMS data coordination of commercial and import testing on site where applicable.
May provide technical guidance.

Required Skills and Qualifications:

Bachelor's degree in a Science related field is required.5+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry.

Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.

Benefits:
We offer a competitive salary package and opportunities for professional growth and development.