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Senior Associate Quality Control
3 weeks ago
Sr Associate Quality Control (NPI)
AMC0007
Contract – 12 months
On Site - South Dublin
The successful candidate will have:
- Bachelors degree in a science field
- 2-3 years experience in QC or GMP lab experience gained in a biopharmaceutical environment. Pharmaceutical and medical device experience will also be considered.
- Experience in regulatory compliance to cGMP in manufacturing and testing of pharmaceutical products
- Strong background in Chemistry and Analytical testing required
Sr Associate Quality Control (NPI)
AMC0007
Contract – 12 months
On Site - South Dublin
The successful candidate will have:
- Bachelors degree in a science field
- 2-3 years experience in QC or GMP lab experience gained in a biopharmaceutical environment. Pharmaceutical and medical device experience will also be considered.
- Experience in regulatory compliance to cGMP in manufacturing and testing of pharmaceutical products
- Strong background in Chemistry and Analytical testing required
- Demonstrate exceptional technical adaptability by seamlessly transitioning across various functions within Quality Control (QC).
- Strategize and execute analyses with efficiency and precision.
- Execute multiple intricate routine and non-routine methods and procedures, encompassing a wide array of assays.
- Compile, evaluate, securely back up, analyze trends, and authorize analytical findings.
- Proactively troubleshoot issues, devise solutions, and engage stakeholders effectively.
- Spearhead the initiation and implementation of revisions in controlled documents.
- Provide comprehensive training support as needed.
- Actively participate in audits, organizational initiatives, and projects, spanning departmental or organizational dimensions.
- Draft protocols, execute assay validation, and oversee equipment qualification/verification processes.
- Introduce innovative techniques to the laboratory setting, overseeing method transfers, report generation, validation procedures, and protocol development.
- Contribute to regulatory filings, ensuring adherence to compliance standards.
- Lead laboratory investigations as required.
- Continuously assess laboratory practices for compliance adherence.
- Authorize laboratory outcomes, ensuring accuracy and reliability.
- Act as a representative of the department/organization across various teams and in interactions with external partners.
- Facilitate data analysis by creating APPX data files and randomization memos.
- Oversee LIMS data coordination for commercial and import testing where applicable.
- Offer technical guidance and support to colleagues.
- Engage in regulatory filings and represent the department/organization on diverse teams.
- Mentor and train team members.
- Foster collaboration with external resources to achieve organizational objectives.
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