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June 22 2018

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Job Offer: QC External Support Specialist - Permanent:

Job description:

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QC External Support Specialist - Permanent

function Description


QC External Support Specialist

Our client, a leading global firm, require a QC external support specialist to join their team in Dublin West . This is a permanent function.

Your The main responsibilities are:
   » Primary Contact responsible for covering commercial product,  analytical queries from Grange Castle regulatory and Global regulatory teams.
   » Technical review and critique of analytical sections/normative documents for all new filing applications for established and new products as directed by QCES manager.
   » Co-ordination and technical review of responses to agency questions on analytical methods.
   » Provide technical support to all new country launches.
   » Provide routine analytical and technical support to contract test labs and contract manufacturers. Maintain regular communications with all contract manufacturing/testing sites via monthly/quarterly meetings as deemed necessary per product.
   » Management of external analytical method transfer projects to rest of world markets and/or contract test laboratories.
   » Management of external analytical method transfer projects to new emerging markets/localisation projects.
   » Support stcapability teams as requested (temp excursions, contract sites stcapability programs, expiry extensions/change control review etc). Act as QCES rep on stcapability review boards.
   » Support importation testing queries and support for rest of world labs via country affiliates and from packing site.
   » Support operations of the Quality Control testing laboratories as requested by QC management.
   » Support MSAT teams to provide QC assessments /information related to analytical test procedures/data trends/other analytical data as required.
   » Lead and participate in continuous improvement projects within the QCES team.
   » Provide support to agency site inspections as required.
   » Host visits to site from Board of Health Laboratories or other government agencies from ROW in support of future import testing requirements locally or as part of new product submissions.
   » Record and review all analytical documentation (method transfer/filing sections etc to cGMP standard.
   » supervise the generation of area SOPs .
   » Implement and adhere to appropriate levels of cGMP within the work area.
   » Perform and assist in additional tasks as may be directed by QC Manager
   » practice with technical elements of the analytical method validation and transfer process.
   » practice with Lab systems an advantage. ( LIMS, CDAS, QTS, PDOCs )

Your practice:
   » B.Sc. degree in biological/chemical sciences, business, or other related technical degree or equivalent practice in regulated industry.
   » 4-6 years significant quality practice as detailed above in the responsibilities section within a QA/QC GMP environment in a Pharma/Biotech company.

Please send CV to cormac.obrien@cpl.ie

Skills:

Job Category: Customer Service [ View All Customer Service Jobs ]
Language requirements:
Employment type:
Salary: Unspecified
Degree: Unspecified
Experience (year): Unspecified
Job Location: Dublin West, Other
Company Type Employer
Post Date: 06/14/2018 / Viewed 15 times
Contact Information
Company:
Contact Email: cormac.obrien@cpl.ie


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