Stability Program Manager

Proffice Life Science AB / Kemistjobb / Södertälje
2013-12-13
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Stability Program Manager

We are looking for a candidate with experience of Quality Assurance and Stability Management within the pharmaceutical industry.

On behalf of our client we are now looking for a Stability Program Manager to be responsible for ensuring compliance with the clients commercial stability obligations by working with the Global Commercial Stability Program.

The assignment is planned to start in January and last until 2013.06.30 with possibility of prolongation.

The Role

The Stability Program Manager will provide submission ready stability data to support license management for global commercial products. You are responsible for the management of the international commercial stability program, through evaluation and trending of stability data, perform stability technical assessments, maintaining overall surveillance of data/issues arising from the international commercial stability program and coordinate investigations that require involvement/co-operation of several sites involved in the supply chain of the affected products.

You are also responsible for ensuring the integrity of stability study reports intended for submission to regulatory agencies and for providing expert stability knowledge and product overview for assigned products.

Business: Proffice Life Science

City: Södertälje

Job type: Full time

Deadline for applications: 2013.12.30

More information: Linda Nord, 073-3434654

Qualification

• Master Degree in Chemistry or equivalent
• At least 3 years experience in Pharmaceutical Production, Quality Assurance, Quality Control, Regulatory Affairs or Analytical or Formulation Development within R&D
• Good awareness of pharmaceutical stability testing, stability management processes or regulatory requirements related to global stability management and cGMP.
• Knowledge of or experience in analytical chemistry
• Strong experience in use of IT Software (document and laboratory information management systems such as SAP/LIMS)
Skills and Capabilities

• Strong communication skills (listening, verbal and written in Swedish and English)
• Excellent team working skills
• Accurate and thorough information handling
• Recognize different perspectives and is able to communicate well with others to influence positive outcomes.
Other qualifications

• Proactive approach to the job accountabilities and responsibilities
• Focus on delivery under pressure

Please send your application in English and apply at our website. We encourage you to send your application as soon as possible, since interviews and candidate selection are done continuously! We put great emphasis on personal suitability for this role.

Organization/Business description:
Proffice Life Science is the leading Nordic specialist of temporary recruitment services within the Biotech and Chemtech industries. We are able to provide our Nordic clients with highly skilled and experienced specialists from all over Europe.

All consultants, employed by Proffice, are specialists. Proffice is one of the largest and most well-renowned staffing agencies in Sweden. All consultants, hired by Proffice, have secure and permanent employment contracts with a certified staffing agency. We offer excellent benefits and personal development opportunities within a wide range of positions and industries.

Our clients expect only the best from Proffice and we expect only the best from our consultants. As you will spend your working day on our clients' premises, you will have to not only be an expert in your field, but also a flexible, independent and social member of the team. You thrive on new challenges and welcome new opportunities. If this appeals to you, we offer a stimulating job, with excellent benefits such as private medical insurance, discounted gym membership and further contributions to health care related activities.

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Publiceringsdatum
2013-12-13

Så ansöker du
Sista dag att ansöka är 2013-12-30
Ange följande referens när du ansöker: 200526709
Ansökan kan tyvärr inte göras via e-post.
Klicka på denna länk för att göra din ansökan

Kontakt
Linda Nord 073-3434654 linda.nord@proffice.se

Företag
Proffice Life Science AB

Adress
Proffice Life Science AB

Jobbnummer
1729140

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