QA Manager - External Biotech Supply Quality, Dun Laoghaire, Dublin

Office/Project Location: Dun Laoghaire, Dublin

Employment Type: Contract

Work Location:  Hybrid

Pay:  €50 - €55 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.

In support of our diverse portfolio, strong pipeline and the patients that we serve, the Quality organization provides end-to-end Quality oversight across a complex and expansive global footprint. 

Whether it is supplying an early phase clinical trial, manufacturing a commercial product, or distributing product in market, the Quality organization plays an important role to ensure we provides safe, quality products to patients in a compliant way

External Supply Quality provides Quality oversight to our external manufacturing portfolio across DS, DP and FDP for small and large molecule.

Maintenance of External Supply Quality licenses as it relates to global GMP/GDP activities (MIA, ASR, WDA)

Ensuring the review, and where appropriate, preparation and regular update of Quality Agreements with outsourced partners.

Owner and approver of GMP/GDP QMS documents

Support the annual Quality Management Review meeting and co-ordination of any actions from this meeting for implementation.

Preparation and periodic review of Bona Fides

QA approval of deviations/non-conformances ensuring deviations are fully investigated and that remedial measures are implemented to address the root cause of failures and relevant actions are taken to prevent their re-occurrence.

QA approval of change control proposals (third party contractors and internal) and action plans.

Coordinate mock recall task force team to test the recall process in accordance with governing procedures and issuance of report with recommendations and corrective action plans for any deficiencies identified.

Support OpEx programs and champion continuous improvements and initiatives

Authority:

Own Quality record content

Work under minimal direction

Identify opportunities and issues, then determine when escalation is necessary

Proposes revisions to SOPs in area of responsibility

Requirements

Doctorate degree OR

Master’s degree & 2 years of directly related experience OR

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

4+ years of quality and manufacturing experience in biotech or pharmaceutical industry

Bachelor’s Degree in a Science Field

cGMP Experience

Ability to oversee multiple projects simultaneously

Able to successfully manage workload to timelines

Familiarity with basic project management tools

Ability to negotiate a position after taking feedback from multiple sources

Demonstrated ability to consistently deliver on-time, and high-quality results

Ability to operate in a matrixed or team environment

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

Ability to travel +/- 10% of time to domestic and international sites

Package

Contract role - Hourly rate €50 - €55 per hour

Minimum 12 month contract

Contact

Karen McHugh is the consultant managing this position.

If you are a QA Manager 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 QA Managers 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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