Job Details: Senior Associate QA


JobsIreland
Jervis Street
Dublin 1
jobsireland.ie
Senior Associate QA
We&#**Apply on the website**;re looking for a candidate to fill this
position in an exciting company.

* Perform complaint investigation related to product manufactured
including Formulation, Filling, Inspection and Packaging.
* Perform all activities in compliance with Amgen safety standards
and SOPs
* Write, review and approve Standard Operating Procedures in
accordance with Policies.
* Provide Quality support for triage and investigation of Deviations
* Review and approval of Deviations and CAPAs for closure ensuring
compliance with appropriate documentation, whilst ensuring that CAPA
actions address root cause and implementation plan dates are
achievable
* Review/approve production batch records, and associated
documentation in preparation for Qualified Person disposition
activities.
* Review and approve cGMP records (e.g., deviations, CAPA,
protocols, reports & SOP) ensuring compliance with appropriate
documentation
* support continuous improvement and Operational Excellence
initiatives
* Any other tasks/projects assigned as per manager&#**Apply on the
website**;s request.

* University degree. Engineering or Science related discipline
preferred.
* Relevant experience (2 yrs +) working in the pharmaceutical or
biotechnology industry or other combination of experience and
educational background that may otherwise satisfy the requirements of
the role.
* Excellent written and verbal communication skills
* Experience working with dynamic cross-functional teams and proven
abilities in decision makin
* Strong organizational skills, including ability to follow
assignments through to completion
* Demonstrated ability in problem solving and experience in managing
Root Cause Analysis / Non Conformance /Deviation investigations
* Knowledge of applicable Regulatory requirements, and ability to
evaluate compliance issues
* Operational Excellence experience

We&#**Apply on the website**;re looking for a candidate to fill this
position in an exciting company.

* Perform complaint investigation related to product manufactured
including Formulation, Filling, Inspection and Packaging.
* Perform all activities in compliance with Amgen safety standards
and SOPs
* Write, review and approve Standard Operating Procedures in
accordance with Policies.
* Provide Quality support for triage and investigation of Deviations
* Review and approval of Deviations and CAPAs for closure ensuring
compliance with appropriate documentation, whilst ensuring that CAPA
actions address root cause and implementation plan dates are
achievable
* Review/approve production batch records, and associated
documentation in preparation for Qualified Person disposition
activities.
* Review and approve cGMP records (e.g., deviations, CAPA,
protocols, reports & SOP) ensuring compliance with appropriate
documentation
* support continuous improvement and Operational Excellence
initiatives
* Any other tasks/projects assigned as per manager&#**Apply on the
website**;s request.

* University degree. Engineering or Science related discipline
preferred.
* Relevant experience (2 yrs +) working in the pharmaceutical or
biotechnology industry or other combination of experience and
educational background that may otherwise satisfy the requirements of
the role.
* Excellent written and verbal communication skills
* Experience working with dynamic cross-functional teams and proven
abilities in decision makin
* Strong organizational skills, including ability to follow
assignments through to completion
* Demonstrated ability in problem solving and experience in managing
Root Cause Analysis / Non Conformance /Deviation investigations
* Knowledge of applicable Regulatory requirements, and ability to
evaluate compliance issues
* Operational Excellence experience



We need : English (Good)

Type: Permanent
Payment:
Category: Others

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