Tilburg Area, Netherlands
Regulatory Affairs Officer
June 2015 to Present
Regulatory Affairs Officer
May 2014 to June 2015
Regulatory Affairs Specialist
October 2012 to April 2014
Regulatory Compliance Officer
July 2007 to September 2012
Officer Business Support & Regulatory Affairs
2006 to July 2007
QA/ QC Documentalist
2003 to 2006
Katwijk Farma BV
2002 to 2003
Quality Assurance Officer
2002 to 2002
Responsible for a diversity of activities such as writing CMC documentation for international submission, answering Deficiency letters from Health Authorities, providing scientific and registration strategy support during variation review and maintaining contacts and consulting with 3rd parties. Responsible for a diversity of activities such as writing CMC documentation for international submission, answering Deficiency letters from Health Authorities, providing scientific and registration strategy support during variation review and maintaining contacts and consulting with 3rd parties.
What company does Yeraima Griffith work for?
Yeraima Griffith works for Teva Pharmachemie
What is Yeraima Griffith's role at Teva Pharmachemie?
Yeraima Griffith is Regulatory Affairs Officer
What industry does Yeraima Griffith work in?
Yeraima Griffith works in the Pharmaceuticals industry.
Regulatory Affairs Officer @ Responsible for a diversity of activities such as writing CMC documentation for international submission, answering Deficiency letters from Health Authorities, providing scientific and registration strategy support during variation review and maintaining contacts and consulting with 3rd parties. From June 2015 to Present (7 months) Regulatory Affairs Officer @ From May 2014 to June 2015 (1 year 2 months) Regulatory Affairs Specialist @ • Drawing up CMC documentation for international submissions • Taking part in the review and release of CMC documents • Answering questions from health authorities and coordinating the agency response process • Making proposals to the organization with regard to variations of chemical/ pharmaceutical documents, consulting with the departments involved as well • Provides scientific and registration strategy support during variation review • Maintaining contacts and consulting with other MSD departments and sister companies From October 2012 to April 2014 (1 year 7 months) NetherlandsRegulatory Compliance Officer @ Regulatory Compliance Officer •Responsible for managing and revising quality documents •Responsible for solving quality issues with both customers and internal departments •Writing / amending / reviewing Registration files (CTD Module 3) •Responsible for keeping submissions and licenses updated •Responsible for revising/drafting relevant laboratory documents after changes in the Pharmacopeia, Technical Files or other guidelines Quality Responsible: •Responsible for releasing to the market products in food/cosmetics category From July 2007 to September 2012 (5 years 3 months) Officer Business Support & Regulatory Affairs @ • Responsible for regulatory procedures and changes applicable to MicroSafe • Responsible for keeping submissions and licenses updated • Responsible for advising the impact of federal regulations on the company • Responsible for the proposals, contract negotiations, contract administration and customer contact activities • Responsible for scientific support to Sales division of Millipore From 2006 to July 2007 (1 year) QA/ QC Documentalist @ • Responsible for writing and revising laboratory documents e.g. Standard Operating Procedures, Lab Records, Test Records and validation protocols • Responsible for keeping the documentation system up-to-date and drafting documentation action plans • Responsible for writing investigation reports • Responsible for revising relevant laboratory documents after changes in the Pharmacopeia or other guidelines From 2003 to 2006 (3 years) Release Officer @ • Responsible for writing and revising Standard Operating Procedures and Validation Protocols • Consulting with several departments inside the company • Responsible for maintaining contact with customers and suppliers • Responsible for solving quality issues with both customers and suppliers of raw materials • Responsible for writing sampling procedures for the Quality Control Inspectors • Responsible for assigning expiration date to final products after laboratory tests • Responsible for the release of batch and packaging records, raw materials and ready-made products From 2002 to 2003 (1 year) Quality Assurance Officer @ • Responsible for the inspection and release of products in quarantine • Responsible for drafting product specifications • Responsible for the inspection of production and packaging documents • Responsible for checking mock-up of product instructions and boxes From 2002 to 2002 (less than a year) MSc., Biopharmaceutical Sciences @ Leiden University From 1996 to 2000 Yeraima Griffith is skilled in: Regulatory Affairs, Quality Assurance, CTD, SAP, High Level Of Accuracy, GMP, Software Documentation, Quality Control, Validation, CAPA, CMC, Change Control, GxP, Pharmaceutics, Sop, SOP, GLP, FDA
Introversion (I), Sensing (S), Thinking (T), Judging (J)
1 year(s), 9 month(s)
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