Biotech External Supply QA Analyst - Remote

Biotech External Supply QA Analyst - Remote - Dun Laoghaire, Dublin

Office / Project Location : Dun Laoghaire, Dublin

Employment Type :  Contract

Work Location :    Remote

Pay : €45 - €55 per hour

Experience :  2+ 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.

You will be part of the Global Supply Quality team supporting oversight and maintenance of contract manufacturers.

Act as disposition manager ensuring that batch disposition activities are completed in line with standards

Manage and drive Quality records to closure including deviation records, investigation reports

Initiate Quality records for supplier related changes.

Collaborate with Complaints team to request assessments, reviews complaint report and have comments addressed

Provide data to the networks to support Quality Management Processes)

Prepare, review and approve SOPs and other GMP / GDP documentation in compliance with corporate and regulatory requirements, to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations.

Take part in operational and quality improvement initiatives, programs, and projects.

Communicate effectively with stakeholders, ensuring alignment on quality objectives and compliance needs.

Requirements

Bachelor’s degree & 4 years of directly related experience OR

Working foundation in quality assurance roles.

Minimum of 4 years working in a cGMP manufacturing environment with a strong understanding of regulatory requirements and expectations.

Ability to have a positive impact on others; the ability to affect the behaviors of others by connecting with and inspiring them

Previous experience in batch release activities

Good working knowledge of SAP

Experience in investigations, project management and trending and analysis

Relevant experience in Supplier Management, raw materials, packaging components, and / or device manufacturing.

Understanding of the applicable manufacturing / testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes).

Proven experience in designing and / or improving processes at conceptual level

Desire to partner with internal and external stakeholders across teams

Understanding of industry requirements / expectations of a robust Quality Management System and documentation.

Excellent analytical and troubleshooting skills.

Strong verbal and written communication skills

Ability to work effectively with global, virtual teams

High degree of initiative and self-motivation.

Ability to manage multiple priorities successfully.

Team-oriented, with a focus on achieving team goals

Strong presentation and public speaking skills.

Package

Contract role - Hourly rate €45 - €55 per hour

Minimum 12 month contract

Onsite expectations : Fully remote. There could be requirements to go on to the Dun Laoghaire site as that’s the location the team are aligned to, but onsite expectations are not on a regular frequency.

It’s just as needed, but the role is considered fully remote.

We anticipate that we would need the individual to come onsite at least once a quarter, and there could be the occasional ad-hoc requirement to go onsite.