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Senior Associate Quality Control NPI
Reference: | RK3640 | Location: |
Dublin |
Qualification: | Degree | Experience: | 3-4 Years |
Job Type: | Fixed Term Contract | Salary: | Not Disclosed |
Senior Associate Quality Control NPI
RK3640
12 Months
Dublin
We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
Duties:
• QC Representative for NPI activities and routine Product meetings
• Assist with activities related to QC projects and/or QC tasks within Site projects
• Plan and perform non-core testing related to NPI activities
• Manage all sample management activities related to NPI activities throughout the site
• Create/own and approve protocols, sample plans, SOP and documentation related to NPI
• QC Representative responsible for Method Validation and Transfers co-ordination and readiness
• Responsible for their own training and safety compliance.
• Sample shipments and temperature monitoring activities for NPI activities
• LIMS data coordination of non-core (NPI) activities.
• 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.
Education and Experience :
- Bachelor’s degree in a Science related field is required.
- 3 years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry.
- Strong background in Chemistry and Analytical testing is required.
- Experience with HPLC, Troubleshooting and Empower is required
If interested in this posting please feel free to contact Rachel Kent on +353 (0)87 427 8808 or [email protected] for further information.
Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
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