QA specialist
Proffice Life Science AB / Kemistjobb / Lund
Observera att sista ansökningsdag har passerat.
Visa alla kemistjobb i Lund,
Lomma,
Staffanstorp,
Burlöv,
Kävlinge eller i
hela Sverige Visa alla jobb hos Proffice Life Science AB i Lund,
Malmö,
Eslöv,
Svedala,
Vellinge eller i
hela Sverige We are looking for you who has thorough understanding of quality systems and has several years of work experience working in Quality Assurance, Quality control, to support the manufacturing of drugs, biologics or devices. We can offer you an diversified challenge in a global company which oversees EU Quality operations, including bur not limited to, contract manufacturing operations, supply chain operations and supplier quality functions.
You will be responsible for leading, monitoring and supporting the quality performance of European quality systems according to GMP & GDP standards. Main responsibilities will be:
• Reviewing batch documentation, data, COAs and supporting QP functions
• Supporting batch disposition
• Designing and implementing European quality systems and maintaining and improving quality metrics
• Approving and leading deviations, change controls, CAPA, investigations and nonconformance reviews, etc.
• Leading drug product complaints and support any recall efforts in conjunction with QP
• Conducting external audits independently as lead auditor
• Support Product Quality Review
• Participating in technology transfer, process scale-up, and process improvement projects.
• Leading meetings with external parties representing Shire in a professional manner.
• LIMS
• SAP
The job requires that you are able to travel approximately 20% (domestic and international) and to work during routine business hours but be flexible to cover US business hours when needed.
Qualifications: It is essentiell that you have an academic education and about 5-7 years of experience working in Quality Assurance, Quality Control, to support the manufacturing of drugs, biologics, or devices. You have a thorough understanding of quality systems and cGMPs and have experience in conducting audits. Interpersonal skills are important for both internal end external contacts and its essential that you read, speak and write English.
It is beneficial if you also have Quality experience in parenteral biotech manufacturing (aseptic or sterile processing), experience working with a Qualified Person, are a Certified Quality Auditor or Engineer and/or have experience from LIMS and SAP.
As a person you preferably are/have the following traits: flexible, organized, able to prioritize, able to critical thinking, able to multi-task and able to work independently.
Employer: Proffice Life Science
Location: Lund
Application deadline: We will have ongoing interviews and we recommend you to apply as soon as possible.
Further information: Please contact Christina Bohlin, +46(0)733 434005,
christina.bohlin@proffice.sePubliceringsdatum2013-01-24Så ansöker duSista dag att ansöka är 2013-02-13
Ange följande referens när du ansöker: 200389662
Ansökan kan tyvärr inte göras via e-post.
Klicka på denna länk för att göra din ansökanKontaktChristina Bohlin
FöretagProffice Life Science AB
AdressProffice Life Science AB
Jobbnummer 1448267
Observera att sista ansökningsdag har passerat.