Sivan Goldberger

Sivan Goldberger Email and Phone Number

Sterile Products Quality Manager @ Teva Pharmaceuticals
5 Basel Street, Petach Tikva, 49131, il
Sivan Goldberger's Location
Bat Hefer, Center District, Israel, Israel
Sivan Goldberger's Contact Details

Sivan Goldberger work email

Sivan Goldberger personal email

n/a
About Sivan Goldberger

During the 3 years I have been working as QA in TEVA, I moved up the professional latter, playing the part for different and challenging roles.I started as QA for the analytical laboratories where I led and contributed to the promotion of lab investigations closure and many other lab projects all the while maintaining high quality standards. In order to achieve the company's goals and system requirements the job demanded excellent teamwork and complete collaboration and partnership with the lab personnel (lab managers, team leaders, supervisors, investigators, planners, analysts) as well as constant communication and cooperation with other site interfaces such as Production, Supply Chain, R&D, Analytical Compliance, Regulation etc.Along with serving as Lab's QA, I accepted the role of QA Referee for the BQC labs in ABIC site. A role that required multitasking while working with several interfaces simultaneously. In principle I served as Site QA for the lab and all the BQC's and Animal House supporting departments (Compliance, Maintenance & Engineering, IT, Validation and Facility). Furthermore, I accompanies several regulatory audits (MOH, Takeda) and performed audits for external suppliers.After 2 years, I achieved the role of QA/QC Laboratories SME (Site Material Expert) where I served as professional manager for the QA/QC team, in charge of assignments and prioritization as well as personnel training and new employees' qualification. Moreover, I performed oversight for all the seven different laboratories (Analytical, Biological, Microbiological and Physical).As my last role in which I serve today, I am part of the Sterile Products quality manager's team. I am in charge of Quality projects related to pivotal clinical batches and validation operations such as Introducing new products to the site, site transfers, alternative suppliers, validation assessments and other subjects as needed.

Sivan Goldberger's Current Company Details
Teva Pharmaceuticals

Teva Pharmaceuticals

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Sterile Products Quality Manager
5 Basel Street, Petach Tikva, 49131, il
Website:
tevapharm.com
Employees:
10
Sivan Goldberger Work Experience Details
  • Teva Pharmaceuticals
    Sterile Products Quality Manager
    Teva Pharmaceuticals Jul 2021 - Present
    Kefar Sava, Central, Israel
    • In charge of quality projects related to pivotal clinical batches and validation operations and quality aspects relating to regulatory affairs.• Oversee implementation of SOP related to pivotal and validation batches.• Managing investigation of manufacturing deviations including risk assessments and implementation of corrective actions.• Managing Change Controls.• Reviews and approves pivotal and validation reports, validation assessments and alternative supplier batch reports.• Acts as QA representative for the plant production development and MS&T teams.• Preparation, update and approval of analytical specifications.• Update and approval of batch manufacturing and packaging procedures.
  • Teva Pharmaceuticals
    Qa/Qc Laboratory Sme
    Teva Pharmaceuticals Jan 2021 - Jul 2021
    Kefar Sava, Central, Israel
    • Professional management of the QA laboratory team:- Scheduling and managing assignments.- Participation in management meetings• Oversight of SOP, cGMP and other Quality aspects implementation for seven different laboratories (Finish products, Raw material, Biological, Biopharma, Packaging, Microbiological and TAPI labs): - Online and offline professional consultation to the laboratories.- Walkthrough inspections and internal quality audits.- Personnel training.• Participation and representation in client/regulatory audits. Ensures that corrective actions are implemented and effective.• Continuation of the QA/QC laboratory duties
  • Teva Pharmaceuticals
    Qa Referee For Biological Quality Control In Abic
    Teva Pharmaceuticals Jan 2019 - Jan 2021
    Tel Aviv, Israel
    • Auditing of laboratory and animal house operations• Walkthrough inspection and internal quality audits of laboratory and animal house• Informal inspection of laboratory operations and test documentations• Deviation investigations• Oversight and approval of Laboratory OOS and OOC investigations• Review and approval of protocols and reports of validation and tech transfers• Review and approval of Standard Operation Procedures (SOP), Working Instructions (WI), Operational Instructions (OI), Instrument Performance (IP). • Implementation of SOP relating to equipment, systems and computerized systems and compliance with relevant requirements of quality systems according to cGMP. • Review and approve installations, qualification, validation and re-qualification protocols and reports of equipment, systems and computerized systems.• Review and approve equipment, systems and computerized systems change controls, work orders, system deviations, CAPA's and other maintenance activities• Regulatory Inspection
  • Teva Pharmaceuticals
    Qa Analytical Qc Laboratory
    Teva Pharmaceuticals Sep 2018 - Dec 2020
    Kefar Sava, Central, Israel
    • Review and approve Out of Specification\ Out of Alert Limit\ Atypical results Investigation• Manages and approves investigations relating to deviations of Raw Materials and Packaging Materials• Review and approve change control and equipment's installation\ Changes \ retirement of laboratory equipment.• Review and Approve actions regarding Pharmacopoeial updates.• Review and Approve laboratory related documents.• Working with multiple interfaces in Kfar Saba Site
  • Teva Tapi
    Analytical Chemist
    Teva Tapi Apr 2012 - Aug 2018
    Netanya, Central, Israel
    • Quality control under GLP/GMP while using advanced analytical instruments• Following Tech Transfer and validation Protocols.• Implementation of new methods and projects.• Writing protocols, investigations, SOP, justifications and other formal reports.
  • Fruitura Bioscience Ltd.
    Research And Development Chemist
    Fruitura Bioscience Ltd. Sep 2009 - Aug 2011
    ReẖOvot, Central, Israel
    • Quality control and HPLC method development for extraction and quantitation of natural materials
  • The Hebrew University Of Jerusalem
    Teaching Assistant
    The Hebrew University Of Jerusalem Sep 2010 - Jun 2011
    ReẖOvot, Central, Israel
    Teaching Assistant for B.Sc. students in the chemical lab

Sivan Goldberger Education Details

Frequently Asked Questions about Sivan Goldberger

What company does Sivan Goldberger work for?

Sivan Goldberger works for Teva Pharmaceuticals

What is Sivan Goldberger's role at the current company?

Sivan Goldberger's current role is Sterile Products Quality Manager.

What is Sivan Goldberger's email address?

Sivan Goldberger's email address is si****@****arm.com

What schools did Sivan Goldberger attend?

Sivan Goldberger attended The Hebrew University Of Jerusalem, Rupin Academic Center.

Who are Sivan Goldberger's colleagues?

Sivan Goldberger's colleagues are Kuldeep Nagar, Paweł Suski, Qasim Choudhary, Basam Hlime, Sudeepta Kumar, Michael Galvin, Ignacio Gutiérrez Mariscal.

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