QC Associate

The Role:

PE Global are recruiting for a Senior QC Associate, NPI to be based onsite in Dun Laoghaire.
Under minimal supervision the person will be 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

This role will support QC and manufacturing operations

Duties & Responsibilities:

• QC Representative for NPI activities and routine Product meetings
• Assist with activities related to QC projects and/or QC tasks within Site project
• 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.
• Plan and perform analyses with great efficiency and accuracy.
• Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
• Report, evaluate, back-up/archive, trend and approve analytical data.
• Initiate and/or implement changes in controlled documents.
• 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.
• 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

Qualifications & Experience:

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

• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
• Working knowledge of aseptic compliance within the manufacturing environment and demonstrated leadership and communication skills to communicate requirements to colleagues
• Auditing documentation and operation process
• Demonstrated ability to interact with regulatory agencies
  Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
• Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)
• Take initiative to identify and drive improvements
• Demonstrated ability to work independently and deliver right first-time results

Interested candidates should submit an updated CV.

Please click the link below to apply, call Sean Fitzsimons on +353 21 4297900 or alternatively send an up to date CV to sean.fitzsimons@peglobal.net