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QA/QP Specialist ** THIS POSITION LOCATED IN LEUVEN,BELGIUM***
Durham, NC
Job Description
KBI Leuven is working on many different projects and is searching for a QA/QP Specialist to join their ambitious small sized team located in Leuven, Belgium.
Responsibilities:
Under the direction of the Head QA Leuven site, the QA/QP Specialist will be responsible for:
• Performing the Qualified Person (QP) function as regards Batch certification, as defined by Directive 2001/83/EC and Annex 16
• Providing Quality Assurance expertise in driving operational activities associated with Global Clients (as a Contract Laboratory Organizations) engaged in analytical activities
• Being the central QA point of contact for investigations/deviations/out-of-specifications audit observations associated with analytical activities in the laboratory
• Reviewing protocols, summary reports, SOPs, CAPA's and internal specifications to ensure that documentation is accurate and complete
• Performing the review of testing documentation and be supportive of deviation investigation, retrieving and collecting supportive information to allow impact assessment
• Participating as QA representative to the recurrent Client meetings, presenting quality issues and resolutions, and drive quality performance through these meetings
• Ensure monthly metrics are gathered and communicated in a timely way
Business system - Process & Compliance:
• Make sure we are adhering strictly to the EU Guidelines on GMP of Medicinal Products with a strong assessment of compliance and the maintenance of the QMS
• Driving/Supporting projects related to quality system improvement
• Maintaining GMP compliance and inspection/audit readiness. Support Head of site Quality Operations in the inspection/audit preparation activities, during inspection/audit and for closure of inspection/audit observation with associated CAPA commitments, Assisting in inspections by Regulatory Authorities
• Keeping up to date with legislative and Regulatory Developments and advise of system changes
Profile:
• 6 - 8 years’ experience in pharmaceutical Industry with operational GMP experience (Analytical QA/QC) would be a distinct advantage
• Registered in Belgium to act as a QP
• Must be knowledgeable in several areas of the global pharmaceutical industry, including the interpretation and practical application of applicable regulations. Has a deep knowledge of the pharmaceutical industry from a business and analytical and technical perspective
• Experienced in interaction with regulatory bodies and third-party organizations with respect to QA systems and regulatory inspection preparedness
• Must have high analytical capabilities, be customer-oriented having mindset oriented to right first time and adherence to plan contributing to the client satisfaction
• Must possess excellent interpersonal, verbal, and written communication skills at all levels internally and externally, with demonstrated interest for continuous improvements and operational excellence initiatives
• Must be able to fluently communicate both in English language and in French language (reading, writing, speaking, comprehension when listening) and Dutch (which will be an additional asset)
• Excellent organization skills, with flexibility drive to lead and achieve multi scope projects
KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.
Responsibilities:
Under the direction of the Head QA Leuven site, the QA/QP Specialist will be responsible for:
• Performing the Qualified Person (QP) function as regards Batch certification, as defined by Directive 2001/83/EC and Annex 16
• Providing Quality Assurance expertise in driving operational activities associated with Global Clients (as a Contract Laboratory Organizations) engaged in analytical activities
• Being the central QA point of contact for investigations/deviations/out-of-specifications audit observations associated with analytical activities in the laboratory
• Reviewing protocols, summary reports, SOPs, CAPA's and internal specifications to ensure that documentation is accurate and complete
• Performing the review of testing documentation and be supportive of deviation investigation, retrieving and collecting supportive information to allow impact assessment
• Participating as QA representative to the recurrent Client meetings, presenting quality issues and resolutions, and drive quality performance through these meetings
• Ensure monthly metrics are gathered and communicated in a timely way
Business system - Process & Compliance:
• Make sure we are adhering strictly to the EU Guidelines on GMP of Medicinal Products with a strong assessment of compliance and the maintenance of the QMS
• Driving/Supporting projects related to quality system improvement
• Maintaining GMP compliance and inspection/audit readiness. Support Head of site Quality Operations in the inspection/audit preparation activities, during inspection/audit and for closure of inspection/audit observation with associated CAPA commitments, Assisting in inspections by Regulatory Authorities
• Keeping up to date with legislative and Regulatory Developments and advise of system changes
Profile:
• 6 - 8 years’ experience in pharmaceutical Industry with operational GMP experience (Analytical QA/QC) would be a distinct advantage
• Registered in Belgium to act as a QP
• Must be knowledgeable in several areas of the global pharmaceutical industry, including the interpretation and practical application of applicable regulations. Has a deep knowledge of the pharmaceutical industry from a business and analytical and technical perspective
• Experienced in interaction with regulatory bodies and third-party organizations with respect to QA systems and regulatory inspection preparedness
• Must have high analytical capabilities, be customer-oriented having mindset oriented to right first time and adherence to plan contributing to the client satisfaction
• Must possess excellent interpersonal, verbal, and written communication skills at all levels internally and externally, with demonstrated interest for continuous improvements and operational excellence initiatives
• Must be able to fluently communicate both in English language and in French language (reading, writing, speaking, comprehension when listening) and Dutch (which will be an additional asset)
• Excellent organization skills, with flexibility drive to lead and achieve multi scope projects
KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.
Job Summary
Company
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
6 years
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