Iva Javorková

Current

• Validation Engineer at Pfizer Australia

Past

• Validation Engineer/Coordinator at Australian Blister Sealing
• Validation Engineer at Pfizer Australia
• Quality Validation Assurance Engineer at NNE Pharmaplan, Denmark (Czech Republic office)

• QC specialst and officer at Medochemie Ltd. Cyprus
• QA specialist at Lonza Biotec, Switzerland (Czech Republic plant)

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Education

• Vysoká škola chemicko-technologická v Praze

Recommended

2 people have recommended Iva

Connections

39 connections

Industry

Packaging and Containers

Iva Javorková’s Summary

Iva is experienced VALIDATION ENGINEER with 4 years of experience acquired on validation and qualification field in pharmaceutical area. Additionally almost 1 year of leading team up to 4 people. Now seeking next rewarding career opportunity to demonstrate abilities in a successful team. Want to be not only specialist with ability to develop, plan and carry out validation activities, but moreover the expert with deep and very detail knowledge.

Iva Javorková’s Specialties:

Validation / Qualification for pharma & biotech
PI&Ds, Layouts, DS, URS, FS
FAT, SAT,Clean Rooms (A-D)
PV - IQ, OQ, PQ
VMP, plans, protocols, reports, cleaning validation protocols
basics of ATEX, commissioning
ATEX, ISO 9001: 2000, Internal auditor certificate holder, GMP, GEP, GLP, FDA, GAMP, audits internal, customer and supplier, change control,deviations,non-conformities,CAPA
Software & PLC/HMI validation

Iva Javorková’s Experience

• Validation Engineer

  Pfizer Australia

  (Pharmaceuticals industry)

  September 2009 — Present (4 months)

  Cleaning validation of packaging lines + manufacturing core area, IQ+OQ equipment + process (plans, protocols, reports)
  Calculations of product contact surface areas
  Computer, Automation & Software Validation (MS Excell, PLC, HMI) in compliance with GAMP 5 (category 3 & 4)
  Cleaning Validation Master Plan
  SOP's writing & training for equipments
  
  Experience in the qualification of packaging equipment, facilities, utilities, systems and/or processes (blister line, bottle line, wet line)
  All activities were conducted in compliance with TGA code

• Validation Engineer/Coordinator

  Australian Blister Sealing

  (Packaging and Containers industry)

  June 2009 — September 2009 (4 months)

  Packaging for PHARMACEUTICALS
  IQ, OQ, PQ for therapeutics & non-therapeutics packaging lines
  Cleaning Validation for blistering line
  Clean Rooms ISO Class 8 & 9
  TGA & GMP compliance

• Validation Engineer

  Pfizer Australia

  (Pharmaceuticals industry)

  May 2009 — June 2009 (2 months)

  Stand-in 1 month contract role
  
  Writing of final PQ report for packaging line - rejection Visio Camera system
  Preparation of PV protocol for ointment's products including packaging line
  Writing of Raw Material Evaluation Report, Technical Report and Periodic Review Assessment Report

• Quality Validation Assurance Engineer

  NNE Pharmaplan, Denmark (Czech Republic office)

  (Privately Held; Pharmaceuticals industry)

  January 2008 — March 2009 (1 year 3 months)

  VALIDATION DUTIES:
  Qualification and validation of production plants, equipments, IQ+OQ (plans, protocols, reports), Commissioning + Mechanical completion (plans, protocols), VMP, RA (BRA-DRA- based on FMEA principles)
  Site validation manager for Synthon project, Blansko, Unit 1 – High Potent API, coordination and managing of all qualification and validation activities. Team leader (2 persons)
  Experience in the qualification of pharma equipment, facilities, utilities, systems and/or processes (mills, microniser, dryers, centrifuges, reactors, pumps, pressurised air system, nitrogen system, HPW)
  QA DUTIES:
  Consulting in GMP and QA areas, managing vendor’s documentation, ATEX issues, knowledge of PED 1997/23 and Machine directive
  Preparation and maintain documentation for ISO 9001: 2000 audit, basics of ISO 9001: 2008
  Office stuff training for new and re-issued SOP's

• QC specialst and officer

  Medochemie Ltd. Cyprus

  (Pharmaceuticals industry)

  February 2006 — August 2007 (1 year 7 months)

  Position (09/2006-08/2007) - Analytical specialist QC and officer: Writing analytical SOPs and performing analytical methods for dosage forms such as tablets, capsules, powder for injections, ampoules or powders for oral suspensions (Including testing of cephalosporin’s and penicillin’s groups)according to cGMP/GLP rules. I perform analytical methods e.g. HPLC (Waters, Varian), FTIR, UV/VIS, titrations, dissolutions, disintegrations, friability etc.
  
  Position 02/2006-09/2006 - Regulatory Affairs officer: Prepare E.U. compliant registration dossiers (CTD format) for products, prepare registration dossiers for non E.U. territories, assemble registration dossiers from core registration data files, prepare renewal registration documentation, prepare, as necessary, documentation to support variations of registrations, provide the necessary information to enable all departmental databases to be maintained in an accurate and up-to-date manner.

• QA specialist

  Lonza Biotec, Switzerland (Czech Republic plant)

  (Public Company; LONN; Biotechnology industry)

  July 2005 — February 2006 (8 months)

  VALIDATION DUTIES:
  Reviewing of cleaning validation protocols
  Participation on issuing cleaning validation protocols
  QA DUTIES:
  All documentation kept in compliance with cGMP, HACCP, FAMI-QS, ISO 9001:2000, Halal and Kosher, FDA and SÚKL (Czech State Institute for Drug Control) requirements
  Dealt with out of specification products (OOS)
  Participation on audits (external, customer’s, internal)
  Dealt with change control documentation, CAPA, non-conformities, deviations issued SOP’s, batch records, protocols (all documentation for production and labs (analytical + microbiological)

Iva Javorková’s Education

• Vysoká škola chemicko-technologická v Praze

  Ing. , Applied biology and bioengineering branch , 1998 — 2005

  Activities and Societies:

  2005 participation on Conference of yeast and beer technology
  2004 participation on Student Scientific Conference (competition) - 1st place
  2003 participation on Student Scientific Conference (competition) - 2nd place

Additional Information

Iva Javorková’s Groups:

since 1997 member of Czech Chemical Society

•    ValidationExperts
•    Pharma Validation Group

Iva Javorková’s Contact Settings

Interested In:

• career opportunities
• job inquiries
• expertise requests
• business deals
• reference requests
• getting back in touch