Ales Premzl Email & Phone Number | • QA Senior Manager - main responsibilities at my current position include leading change management processes (pre- and post- approval) within site quality management system according regulatory and internal company requirements as well as leading site FDA readiness project. • Head Analytical Services - management of the QC activities that support IPC, release and stability testing to assure compliance of the QC system with official regulations, Health Authorities requirements and internal company requirements. Major responsibilities: analytical method transfers and validation, evaluation and implementation of new technologies, providing troubleshooting support and expertise to QC laboratory, qualification of contract laboratories, reference standards qualification, stability program management. • Head Quality Control - experience in managing activities of Quality Control department in Biopharmaceuticals, leading a team and working in a multinational environment. Responsibilities include developing profesional expertise in quality control of biopharmaceutical APIs and FDFs, planning and execution of protein and glycoprotein analyses, IPC, release and stability testing, analytical method implementation, transfer and validation with focus on compliance with cGMP requirements, ICH guidelines, EU, FDA and internal company regulations/directives/standards. • Global Regulatory CMC Manager - experience in preparation of regulatory CMC documentation to support registration activities of new global products and maintenance of the CMC portion of existing global product registrations for biosimilars, including writing/reviewing of the appropriate parts of the existing registration dossier; ensuring that the required CMC documents are generated to the appropriate quality by advising technical experts in analytics.

Ales Premzl

• QA Senior Manager - main responsibilities at my current position include leading change management...
Slovenia

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Ales Premzl’s Email ales.premzl@sandoz.com

Ales Premzl’s Phone Numbers +1 609-627-****

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Ales Premzl’s Location Slovenia

Ales Premzl’s Current Industry Sandoz

Ales Premzl’s Prior Industry Jozef Stefan Institute

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Work Experience

Sandoz

Qa Senior Manager

2013-04-01 00:00:00 - Present

Jozef Stefan Institute

Young Researcher & Postdoctoral Researcher

1998-12-01 00:00:00 - 2007-11-01 00:00:00

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FAQ About Ales Premzl

Ales Premzl is located at
Slovenia

Ales Premzl is a • QA Senior Manager - main responsibilities at my current position include leading change management processes (pre- and post- approval) within site quality management system according regulatory and internal company requirements as well as leading site FDA readiness project. • Head Analytical Services - management of the QC activities that support IPC, release and stability testing to assure compliance of the QC system with official regulations, Health Authorities requirements and internal company requirements. Major responsibilities: analytical method transfers and validation, evaluation and implementation of new technologies, providing troubleshooting support and expertise to QC laboratory, qualification of contract laboratories, reference standards qualification, stability program management. • Head Quality Control - experience in managing activities of Quality Control department in Biopharmaceuticals, leading a team and working in a multinational environment. Responsibilities include developing profesional expertise in quality control of biopharmaceutical APIs and FDFs, planning and execution of protein and glycoprotein analyses, IPC, release and stability testing, analytical method implementation, transfer and validation with focus on compliance with cGMP requirements, ICH guidelines, EU, FDA and internal company regulations/directives/standards. • Global Regulatory CMC Manager - experience in preparation of regulatory CMC documentation to support registration activities of new global products and maintenance of the CMC portion of existing global product registrations for biosimilars, including writing/reviewing of the appropriate parts of the existing registration dossier; ensuring that the required CMC documents are generated to the appropriate quality by advising technical experts in analytics.