Validation Engineer/Coordinator at Australian Blister Sealing Company
New South Wales, Australia
- Current
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- Validation Engineer/Coordinator at Australian Blister Sealing
- Past
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- 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)
- Education
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- Vysoká škola chemicko-technologická v Praze
- Recommended
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2 people have recommended Iva - Connections
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34
connections
- Industry
- Packaging and Containers
- Websites
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 2 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, understand to DQ and RA
VMP, plans, protocols, reports, cleaning validation protocols
basics of ATEX, commissioning, mechanical completion, safety ATEX report, ISO 9001: 2000, Internal auditor certificate holder, GMP, GEP, GLP, FDA, HACCP, Halal, Kosher, FAMI-QS, audits internal, customer and supplier, change control,deviations,non-conformities,CAPA
USP, BP, EP
Iva Javorková’s Experience
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Validation Engineer/Coordinator
Australian Blister Sealing
(Packaging and Containers industry)
June 2009 — Present (2 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
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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 Websites:
Iva Javorková’s Groups:
since 1997 member of Czech Chemical Society
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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
