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Senior quality assurance manager

Life Science Recruitment
Qa manager
€80,000 - €100,000 a year
Posted: 17 May
Offer description

Direct message the job poster from Life Science Recruitment


Senior Recruitment Consultant at Life Science Recruitment - Supply Chain ~ Quality ~ Manufacturing

We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties:

* Be an integral quality member of cross-functional contract manufacturing team that includes but is not limited to business operations, analytical science, process development, supply chain XPD etc.
* Negotiator and Approver of quality agreements
* Lead the preparation of the site for and Represent at product-specific Regulatory Inspections and/or during Notified Body audits of CM Site, as applicable or required.
* Present on topics during inspection demonstrating appropriate behaviors and knowledge of the subject areas
* Review / Approve Master Batch Records
* Quality approver for deviations, change controls, CAPA
* Prepare inspection playbooks
* Identify and mitigate Risk at the CMO or testing Laboratories and/or escalate to management
* Perform Person in Plant activities as required
* APR Data Provider
* Manage Audit commitments to completion
* Perform tactical batch disposition activities in support of lot release

Education and Experience :

* Bachelor’s degree in a Science related field is required.
* 10 + years biotech or pharmaceutical industry experience
* Significant Quality experience at Aseptic Manufacturing facilities
* Have a good oversight of deviation management, reg affairs, filings, regulatory, the guidance, e.g., HPRA requirements, so a very broad experience in quality.
* Previously worked in an external manufacturing environment.

If interested in this posting please feel free to contact Rachel Kent on +353 (0)87 427 8808 or rachel.kent@lifescience.ie for further information.


Seniority level

* Seniority level

Mid-Senior level


Employment type

* Employment type

Contract


Job function

* Job function

Manufacturing and Quality Assurance
* Industries

Pharmaceutical Manufacturing and Medical Equipment Manufacturing

Referrals increase your chances of interviewing at Life Science Recruitment by 2x

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