QC Systems Analyst - Biotech Investigations - Dublin


Location: Ireland

EUR 30 - 36 Per Hour

Job Type: Contract

Industry: Biotech-Pharma-Medical-Device-Jobs

Job ID: JO-2405-35302

Consultant: Karen McHugh






Are you a QC Systems Analyst  with 4+ years experience owning Quality Records e.g. Deviation Records, CAPA, ARA and Change Controls in the pharmaceutical or biotechnology industry?

This is a contract role based in Dun Laoghaire, Dublin.

If you have the relevant experience, please forward your CV to karen@jobcontax.com for review or call 353 1 7978720 to discuss in confidence.


QC Systems Analyst - Biotech Investigations - Dublin


Job Description  

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.

QC Systems Senior Associate Investigations is a key member of the QC Systems team. 

They provide support to the QC function for all activities within the site Quality System associated with QC Deviation Investigations, CAPA records, Analytical Results Assessments (ARA) and Change Controls.

The successful candidate will own and manage the end-to-end life cycle of Quality records on behalf of Quality Control. 

The role has a strong focus on technical writing and problem-solving including Root Cause Analysis and 5 Why methodologies.

Triage Management

Quality Record owner

Technical writing for investigations

Ensure timely closure of Quality Records

SME for Root Cause Analysis and 5 Why methodologies

Development of robust CAPA and CAPA Effectiveness Verification in conjunction with area SMEs

Trend Analysis of QC Quality records

Monthly Metrics Management and Reporting

Participate in cross functional Investigations Teams

Lead Continuous Improvement Initiatives

Contribute to success of QC Goals

Support NPI/ Lot Release / Stability linked to Quality Records

Participate in Regulatory Inspections

Ownership of Change Controls Key Values and Competencies:

Work in Teams; Ensure Quality; Be Science Based; Collaborate, Communicate and Be Accountable

Ability to work through Complex Problems

Excellent verbal and written communication skills including technical writing, presentation, and facilitation skills.

Ability to work in a fast-paced environment with changing priorities

Comfortable working under minimal direction


Requirements

Hold a third level qualification in a science related discipline

Have a minimum of 4 years experience in Biopharmaceutical/ Pharmaceutical industries or 2 years in a similar investigator role

Experience owning Quality Records e.g. Deviation Records, CAPA, ARA and Change Controls advantageous

Possess key competencies to include planning/organization, problem solving, excellent verbal and written communication, teamwork, flexibility and adaptability


Package

Contract role - Hourly rate €30 - €36 per hour

Minimum 12 month contract



Contact

Karen McHugh is the consultant managing this position.

If you are a QC Systems 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 Systems Analysts in Dublin and Ireland.

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


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