Quality Assurance Supplier Manager

Experis Engineering Huvudkontor / Organisationsutvecklarjobb / Södertälje
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Experis Engineering erbjuder kompetensförsörjning av tekniska chefer och specialister via konsultverksamhet, rekrytering och projektlösningar. Genom att kombinera vår branscherfarenhet med vår kunskap om människans potential får vi såväl individer som verksamheter att växa och utvecklas. Experis Engineering finns på ett 30-tal orter i Sverige och i mer än 50 länder världen över.

Publiceringsdatum
2014-10-08

Dina arbetsuppgifter
Quality Assurance Supplier Manager
The work place
Global External Sourcing (GES) is a global team of ~ 250 employees, accountable for $1.9bn spend (40% of AstraZeneca's Operation's total spend). The organisation buys and supplies all externally manufactured global Active Pharmaceutical Ingredients (API) and all Formulation and Packing (F&P) Materials. GES also includes Direct Materials for AZ Operations.
AstraZeneca strategy for APIs is to outsource all manufacture and to launch all new APIs from external partners. This strategy requires well developed external capability and high calibre QA Professionals to ensure that AstraZeneca and Global Regulatory standards are met.
The role
The role holder works closely with Supply Chain QA Leaders, Senior QA Supplier Managers and other QA Supplier Managers to support the performance of required QA system and compliance activities for GES supply chains and suppliers. Responsibilities include, but not limited to, batch/product release, deviations investigations, complaints handling and inspection management.
Major Responsibilities:
Evaluates, trends and manages Product Quality Complaints for API, and formulated and packaged products in system (GCM).
Executes batch/product release of formulated and packaged products, active pharmaceutical ingredients, starting materials, medical devices, including:
• Batch documentation review and batch release (as delegated by the Qualified Person) including working in relevant quality management systems (e.g. SAP, GQCLIMS).
• Execution of batch disposition for batches affected by level 1 deviations, assessed by Senior Quality Assurance Supplier Manager or Qualified Persons
• Preparation and approval of certificates within GQCLIMS system and manually.
Other Responsibilities:
• Collaborates with others to facilitate continuous improvement, benchmarks internal and external QA practices to identify innovative efficient and effective practices.
• Supports GES Quality Management Systems:
• Preparation, management and/or coordination of inspections.
Minimum experience/requirements
• Pharmacist, or masters degree in a science / technical field such as Pharmacy, Biology, Chemistry or Engineering, complying with educational requirements as defined in LVFS 2004:7, §7.
• Proven experience in either pharmaceutical operations environment or pharmaceutical Quality Assurance role for at least 2 years.
• Excellent oral and written communication in Swedish and English.
Preferred experience/requirements
• Strong ability and motivation to learn and collaborate.
• Ability to work independently under his/her own initiative.
• Experience working in SAP.
• Should consistently operate across all leadership capabilities on level 2 and with strengths in Passion for Customers, Acts Decisively and Drives Performance.

Vad kan vi erbjuda dig? (OBS! end.uth!)

Application documents must be in English.

Start date: 2014-11-01
Duration: 12 months
Scope: Full time
Career Level: D

Consultantcy job at AstraZeneca.

The selected candidate may have to go through a background check, such as alcohol and drug tests.

Kontaktperson för detta jobb
caroline.lindberg.sen@se.experis.com

Arbetstider och omfattning
100% Enligt överenskommelse

Ersättning
Enligt överenskommelse

Så ansöker du
Sista dag att ansöka är 2014-12-01
Klicka på denna länk för att göra din ansökan

Kontakt
Caroline Sen

Företag
Experis Engineering Huvudkontor

Adress
Experis Engineering Huvudkontor
Klarabergsgatan 29
11181 Stockholm

Kontorsadress
Klarabergsgatan 29

Jobbnummer
2024227

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