QC Analyst - NPIs, Dun Laoghaire, Dublin

Office/Project Location: Dun Laoghaire, Dublin

Employment Type: Contract

Work Location:  Hybrid

Pay:  €20 - €35 per hour

Experience: 3+ years

Visa: EU passport or Stamp 4 visa required

Our client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoighaire, South Dublin. 

The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment. 

This is an excellent opportunity to get experience into Ireland's leading aseptic manufacturing plant.

Under minimal supervision, responsible for one or more of the following activities in QC including analytical testing, characterization, sample and data management.

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.

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, as such some extended hours and weekend work flexibility may be necessary as required.

With a high degree of technical flexibility, work across diverse areas within QC

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.

Troubleshoot, solve 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. May contribute to regulatory filings.

May represent the department/organization on various teams. May train others.

May interact with outside resources

Requirements

Bachelor’s degree in a science discipline.

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.

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

Knowledge:

Understanding and application of principles, concepts, theories, and standards of GMP QC analytical laboratories. Deepens technical knowledge through exposure and continuous learning

Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery

Problem Solving:

Applies analytical skills to evaluate and interpret complex situations/ problems using multiple sources of information

Qualitative information

Quantitative research

Trend data

Anticipates and prevents potential problems

Take initiative to identify and drive improvements

Communication skills (verbal and written) at all levels

Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)

Presentation skills

Escalate issues professionally and on a timely basis

Decision making

Teamwork and Coaching others

Teamwork and Coaching others

Auditing documentation and operation process

Demonstrated ability to work independently and deliver right first-time results

Works under minimal direction

Work is guided by objectives of the department or assignment

Follows procedures

Refers to technical standards, principles, theories, and precedents as needed

May set project timeframes and priorities based on project objectives and ongoing assignments

Recognizes and escalates problems

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

Package

Contract role - Hourly rate €30 - €35 per hour

Minimum 12 month contract

Contact

Karen McHugh is the consultant managing this position.

If you are a QC Analyst interested in roles based in Dublin , you can contact Karen by e-mail at Karen@jobcontax.com Karen or phone 353 1 9696683 for a confidential chat.

JobContax do not send CVs to clients without candidate permission.

With over 50 years of technical recruitment experience, JobContax is the leading recruiter of QC Analysts in Dublin and Ireland.

Due to the large volume of applications, JobContax may not be able to respond to every individuals

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