Ad Details
Location:
Description
auto req 12130br
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:perform duties related to batch reivew and release if required
. drug listing of packaging components with fda
. dossier updates and variation preparation as required.perform other qa duties as required
basic qualifications . submission of documents to corporate regulatory affairs to support variations and dossier updates for multi-national products
. qp qualified candidates.
. support product transfers to dublin site.
. tracking of variation approvals in product markets.prepare quality agreements as required
. participate in market action procedures as required
.
key responsibilities:
. maintenance and review of site master file
.
the successful candidate will report to the senior manager qa and be the primary site contact for regulatory affairs and work closely with both internal and external teams.comparbaility protcools
, g. steirle proecss valiadtion docmuent.review chnage conrtol documetnation to detemrine imapct on quality agreement
. provide documentation to support regulatory filings e.participate in corporate and regulatory audits as required
.
. experience with in regulatory compliance
preferred qualifications . biology or science related discipline, university degree gained in chemistry.perform compliance review on validation protocols and deviation report
. provide documentation to support product renewals (stability data, gmp certificates & certificates of pharmaceutical product (copp)
. review of change control documents to determine impact on product registrations
.
. significant experience gained within the pharmaceutical or biotechnology industry.compile annual product reviews and ensure adherence to schedule
. preparation / update of registration summaries
.
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