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Sr Associate, Quality Assurance

Are you an experienced Quality Professional who thrive in an international, multi-cultural environment where things are constantly changing? Then you might the person we are looking for!

Job Category

Quality

Requisition Number

33222BR

Job Description

We are currently looking for self-driven, positive and proactive team-player to join the QA LSM Operation PMD team in Hillerød. The team consists of 7 employees with whom you will work very closely, and this team forms part of the QA LSM Operations department, consisting of 37 employees with primary responsibility for release of Drug Substance (API) as well as daily support of our large-scale manufacturing facility and related functions. 

Primary Responsibilities
• Act as primary QA contact for external customers/partners regarding day-to-day operational activities and for all Biogen project team involved in the partner collaboration
• Participate in partner Business Review Meetings
• Support review and approval of documentation, deviations, CAPA’s etc. for the partner programs
• Assess all changes related to the partner programs to ensure a proper review of changes that impacts regulatory requirements and product quality
• Support the annual product review for the partner programs
• Perform timely QA review and approval of process performance qualification (PPQ) protocols and reports, continuous process monitoring protocols/reports, risk assessments and sampling plans
• Participate in partner audits and competent authority’s inspections in regards to the partner programs
• Maintain internal training level and keep up to date on cGMPs and regulatory requirements as well as global procedures, guidelines, policies, frames, and specifications

You will work in an international and highly dynamic environment, including collaboration with other internal sites and external partners.

Qualifications

We are looking for a strong team player who can also work independently and who is able to build a partnership relation with stakeholders at all levels. Other skills required:
• Minimum 5 years’ experience from biotech or pharmaceutical industry 
• Knowledge of Good Manufacturing Practice (GMP) 
• Good at making decisions (risk based approach)
• Strong English verbal and written communication skills 
• Demonstrate trouble shooting skills
• Ability to take ownership and responsibility for your assignments
• Positive and pragmatic attitude with focus on priorities and delivery on time

Education

• Master of Sciences or PhD in Pharmacy, Chemistry, Biotechnology or similar

Employment Category

Full-Time Regular

Experience Level

Associate


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329769663Phoenix-9259c58a12018-03-01T17:02:49.813Sr Associate, Quality Assurance

Are you an experienced Quality Professional who thrive in an international, multi-cultural environment where things are constantly changing? Then you might the person we are looking for!

Job Category

Quality

Requisition Number

33222BR

Job Description

We are currently looking for self-driven, positive and proactive team-player to join the QA LSM Operation PMD team in Hillerød. The team consists of 7 employees with whom you will work very closely, and this team forms part of the QA LSM Operations department, consisting of 37 employees with primary responsibility for release of Drug Substance (API) as well as daily support of our large-scale manufacturing facility and related functions. 

Primary Responsibilities
• Act as primary QA contact for external customers/partners regarding day-to-day operational activities and for all Biogen project team involved in the partner collaboration
• Participate in partner Business Review Meetings
• Support review and approval of documentation, deviations, CAPA’s etc. for the partner programs
• Assess all changes related to the partner programs to ensure a proper review of changes that impacts regulatory requirements and product quality
• Support the annual product review for the partner programs
• Perform timely QA review and approval of process performance qualification (PPQ) protocols and reports, continuous process monitoring protocols/reports, risk assessments and sampling plans
• Participate in partner audits and competent authority’s inspections in regards to the partner programs
• Maintain internal training level and keep up to date on cGMPs and regulatory requirements as well as global procedures, guidelines, policies, frames, and specifications

You will work in an international and highly dynamic environment, including collaboration with other internal sites and external partners.

Qualifications

We are looking for a strong team player who can also work independently and who is able to build a partnership relation with stakeholders at all levels. Other skills required:
• Minimum 5 years’ experience from biotech or pharmaceutical industry 
• Knowledge of Good Manufacturing Practice (GMP) 
• Good at making decisions (risk based approach)
• Strong English verbal and written communication skills 
• Demonstrate trouble shooting skills
• Ability to take ownership and responsibility for your assignments
• Positive and pragmatic attitude with focus on priorities and delivery on time

Education

• Master of Sciences or PhD in Pharmacy, Chemistry, Biotechnology or similar

Employment Category

Full-Time Regular

Experience Level

Associate

2018-04-27T00:50:34.467 Are you an experienced Quality Professional who thrive in an international, multi-cultural environment where things are constantly changing? Then you might the person we are looking for! Job Category Quality Requisition Number 33222BR Job Description We are currently looking for self-driven, positive and proactive team-player to join the QA LSM Operation PMD team in Hillerød. The team consists of 7 employees with whom you will work very closely, and this team forms part of the QA LSM Operations department, consisting of 37 employees with primary responsibility for release of Drug Substance (API) as well as daily support of our large-scale manufacturing facility and related functions. Primary Responsibilities • Act as primary QA contact for external customers partners regarding day-to-day operational activities and for all Biogen project team involved in the partner collaboration • Participate in partner Business Review Meetings • Support review and approval of documentation, deviations, CAPA s etc. for the partner programs • Assess all changes related to the partner programs to ensure a proper review of changes that impacts regulatory requirements and product quality • Support the annual product review for the partner programs • Perform timely QA review and approval of process performance qualification (PPQ) protocols and reports, continuous process monitoring protocols reports, risk assessments and sampling plans • Participate in partner audits and competent authority s inspections in regards to the partner programs • Maintain internal training level and keep up to date on cGMPs and regulatory requirements as well as global procedures, guidelines, policies, frames, and specifications You will work in an international and highly dynamic environment, including collaboration with other internal sites and external partners. Qualifications We are looking for a strong team player who can also work independently and who is able to build a partnership relation with stakeholders at all levels. Other skills required: • Minimum 5 years experience from biotech or pharmaceutical industry • Knowledge of Good Manufacturing Practice (GMP) • Good at making decisions (risk based approach) • Strong English verbal and written communication skills • Demonstrate trouble shooting skills • Ability to take ownership and responsibility for your assignments • Positive and pragmatic attitude with focus on priorities and delivery on time Education • Master of Sciences or PhD in Pharmacy, Chemistry, Biotechnology or similar Employment Category Full-Time Regular Experience Level Associate11Jobnet9259c58a100000000000IDK_OFIR_02DKDanmark228DKK2018-04-26T00:00:000010https://goo.gl/CKtfqF0EuropaDanmarkEuropaDanmarkSjælland & øerStorkøbenhavnAllerødEuropaDanmarkSjælland & øerNordsjællandFredensborgEuropaDanmarkSjælland & øerNordsjællandHillerød3124943BIOGEN (DENMARK) NEW MANUFACTURINGApS11Biogen Alle 13400Hillerød77416999DKDanmark155.9220039012.27590210
jom@workindenmark.dkDKDanmarkDKDanmark
8Fuldtid46Permanent533567JobNet47884031000https://dispatcher.ofir.dk/statistic/register?context=FeedEntrySearchedCount&feedId=dc2beb84&entryId=9259c58ahttps://dispatcher.ofir.dk/statistic/register?context=FeedEntryDisplayCount&feedId=dc2beb84&entryId=9259c58ahttps://dispatcher.ofir.dk/statistic/register?context=JobApplicationInitiatedCount&feedId=dc2beb84&entryId=9259c58a&page=ShowJob&component=SendApplicationButtonhttps://dispatcher.ofir.dk/statistic/register?context=JobApplicationAppliedCount&feedId=dc2beb84&entryId=9259c58a&page=EmailApplyForm&component=SendApplicationButtonhttps://static.matchwork.com/company/logo/DK/ORS/SoMe/Oevrige/1.jpgSøger du nye udfordringer indenfor Øvrige?12007991Dansk3Læse/ tale315218Kvalitetsmedarbejder0Øvrige353377289Johannes Molsjom@workindenmark.dkDKDanmarkDKDanmarkda-DK