Ad Details
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Description
auto req 12129br
job posting title sr associate qa
career category quality
employee subgroup salaried ft
country (state/region) ireland
location (city) dun laoghaire
amgen job description overview:qp qualified candidates. maintenance and review of site master file
. comparability protocols
, g. sterile process validation document.compile annual product reviews and ensure adherence to schedule
. provide documentation to supoprt regualtory filings e.dosiser updtaes and variation preparation as required.
. tracking of variation approvals in product markets.review of change control docuemnts to determine impact on product registrations
.
the successful candidate will report to the senior manager qa and be the primary site contact for regulatory affiars and work closely with both internal and external teams.
key responsibilities:
. prepare quality agreements as required
. perform duties related to batch review and release if required
. preparation / update of registration summraies
. submsision of documents to corproate regulatory affairs to support varitaions and dossier updates for mutli-natoinal products
.
. support product transfers to dublin site. perform other qa duties as required
basic qualifications . perform compliance review on validation protocols and deviation report
.
. significant experience gained within the pharmaceutical or biotechnology industry.
. experience with in regulatory compliance
preferred qualifications . review change control documentation to determine impact on quality agreement
. participate in market action procedures as required
. biology or science related discipline, university degree gained in chemistry.drug listing of packaging components with fda
. participate in corporate and regulatory audits as required
. provide documentation to support product renewals (stability data, gmp certificates & certificates of pharmaceutical product (copp)
.
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