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Rachel Kent
Life Science

+353 87 427 8808
[email protected]
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Details

Senior Associate Quality Control NPI


Reference:RK3535 Location: Dublin
Qualification:DegreeExperience:3-4 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: QC Analyst


Senior Associate Quality Control NPI
RK3535
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.


This role is responsible for one or more of the following activities in QC including analytical testing, characterization, sample and data management.

  • Contributes to team by ensuring the quality of the tasks/services provided by self
  • Contributes to the completion of milestones associated with specific projects or activities within team

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.

• LIMS data coordination of commercial and import testing on site where applicable



Education and Experience :

• Bachelor’s degree in a science discipline

• Approximately 2-3 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.


If interested in this posting please feel free to contact Rachel Kent on +353 (0)87 427 8808 or [email protected] for further information.