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QA Specialist

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329827907Phoenix-e9ba803f12018-06-07T00:00:00QA Specialist

We have an exciting new opportunity for an experience QA Specialistl to join our team in Hillerod.

Job Category

Quality

Requisition Number

34929BR

Job Description

We are looking for an experienced Quality Specialist or Delegated QP to join the QA Commercial Finished Product team at Biogen in Hillerød. You will be part of a group of 8 people who has the main responsibility for QA Support to Label & Pack.

In this role, you will assist with maintaining quality systems based on current GMP, GDP and regulatory requirements. You will also assure product compliance through quality systems.

All operations will be performed as per executed training curricula and under appropriate quality systems such as cGMP, 21 CFR part 820 or ISO 13485 as described by Biogen procedures.

Primary Responsibilities
- Review and approval of Finish Good changes and related tasks
- Handling and supporting Global Change Controls
- Coordinates and perform timely approval/closure of deviations, events, including CAPAs and conducts and reports investigations as a result of a quality event if applicable
- Improve and update the systems, documentation and procedures etc. in the department Participate in special projects as defined in the project definitions
- Provide internal training to other departments on quality systems owned by the department
- Participate in internal audits and audits and inspections from regulatory bodies or partners
- Maintain internal training level and keep up to date on cGMPs and regulatory requirements to ensure that Biogen products are manufactures in accordance with their licenses, cGMP and with all regulatory requirements in all markets served
- Originate information on departmental performance and site quality performance over pre-defined time periods on pre-set dates and on request (Annual Product Review (APR), ad-hoc reports)

Qualifications

- Preferably 1-5 years of experience within QA, QC and/or manufacturing within biotech or pharmaceutical industry
- Experience within GMP
- Fluency in spoken and written English

Education

- Master of science in Pharmacy, Engineering or equivalent

Employment Category

Full-Time Regular

Experience Level

Associate

2018-08-03T00:50:20.227 We have an exciting new opportunity for an experience QA Specialistl to join our team in Hillerod. Job Category Quality Requisition Number 34929BR Job Description We are looking for an experienced Quality Specialist or Delegated QP to join the QA Commercial Finished Product team at Biogen in Hillerød. You will be part of a group of 8 people who has the main responsibility for QA Support to Label Pack. In this role, you will assist with maintaining quality systems based on current GMP, GDP and regulatory requirements. You will also assure product compliance through quality systems. All operations will be performed as per executed training curricula and under appropriate quality systems such as cGMP, 21 CFR part 820 or ISO 13485 as described by Biogen procedures. Primary Responsibilities - Review and approval of Finish Good changes and related tasks - Handling and supporting Global Change Controls - Coordinates and perform timely approval closure of deviations, events, including CAPAs and conducts and reports investigations as a result of a quality event if applicable - Improve and update the systems, documentation and procedures etc. in the department Participate in special projects as defined in the project definitions - Provide internal training to other departments on quality systems owned by the department - Participate in internal audits and audits and inspections from regulatory bodies or partners - Maintain internal training level and keep up to date on cGMPs and regulatory requirements to ensure that Biogen products are manufactures in accordance with their licenses, cGMP and with all regulatory requirements in all markets served - Originate information on departmental performance and site quality performance over pre-defined time periods on pre-set dates and on request (Annual Product Review (APR), ad-hoc reports) Qualifications - Preferably 1-5 years of experience within QA, QC and or manufacturing within biotech or pharmaceutical industry - Experience within GMP - Fluency in spoken and written English Education - Master of science in Pharmacy, Engineering or equivalent Employment Category Full-Time Regular Experience Level Associate11Jobnete9ba803f100000000000IDK_OFIR_02DKDanmark228DKK2018-08-02T00:00:000000https://sjobs.brassring.com/TGnewUI/Search/home/HomeWithPreLoad?PageType=JobDetails&noback=0&partnerid=169&siteid=5140&jobid=8103140EuropaDanmarkSjælland & øerNordsjællandHillerød3281455BIOGEN (DENMARK) NEW MANUFACTURINGApS11Biogen Idec Alle 13400Hillerød77416999DKDanmark0
DKDanmarkDKDanmark
8Fuldtid46Permanent586256JobNet48365181000https://dispatcher.ofir.dk/statistic/register?context=FeedEntrySearchedCount&feedId=dc2beb84&entryId=e9ba803fhttps://dispatcher.ofir.dk/statistic/register?context=FeedEntryDisplayCount&feedId=dc2beb84&entryId=e9ba803fhttps://dispatcher.ofir.dk/statistic/register?context=JobApplicationInitiatedCount&feedId=dc2beb84&entryId=e9ba803f&page=ShowJob&component=SendApplicationButtonhttps://dispatcher.ofir.dk/statistic/register?context=JobApplicationAppliedCount&feedId=dc2beb84&entryId=e9ba803f&page=EmailApplyForm&component=SendApplicationButtonhttps://static.matchwork.com/company/logo/DK/ORS/SoMe/Oevrige/1.jpgMed et job indenfor Øvrige får du en spændende hverdag, der byder på mange nye udfordringer. 12007991Dansk3Læse/ tale315218Kvalitetsmedarbejder0Øvrige355492369Biogennoreply@ofir.comDKDanmarkDKDanmarkda-DK