David Batchelor work email
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David Batchelor personal email
I believe Quality Assurance is at its core about information management. Most errors in a modern GMP processes are when the required information to successfully complete the task was missing, incorrect or in a form incompatible to the process. The most common error I find are transcription errors of information between processes and the common cause of major deviation are translation error such as training in a process that requires operator interpretation at the point of use. Many of the changes I have implemented are in-essence a more efficient means of obtaining, transferring, using, and recording information. GMP TrainerQualified AuditorQA Release of GMP Manufactured APIs and aseptic final ProductInterface with NZ (ACVM, Medsafe, MPI) and overseas Regulators.Expert in Overseas market Access requirements (OMAR)NNZCAA approved certificate in Aviation Dangerous goods course for infectious substance regulations
South Pacific Sera
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Development Projects Quality SpecialistSouth Pacific Sera Mar 2022 - PresentWorking with and coordinating development, Production and QC department on establishing new processes and product lines. Revising operations and negotiating with regulatory agencies as a result of introduction of new projects. Introduction of training programs for new project
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Team Leader Qa/Qc OperationSouth Pacific Sera Limited Nov 2019 - Feb 20222IC to Quality Manager. Coordinating between multiple departments in managing the day-to-day operation of the facility, hosted Customer and Regulatory (MPI, ACVM and Medsafe) audits. Coordinating and revising facility qualifications such as HVAC, Compressed air, water and sterilisers -
Acting Quality ManagerSouth Pacific Sera Limited Sep 2018 - Oct 2019Timaru, New ZealandCompany Quality Lead for Quality assurance. Key contact for customer complaints. Responsible for QA Staff recruitment and performance management. Responsible for internal audit and compliance. Responsible for change control and CAPA programs. Responsible for external audit management and corrective actions. Responsible for facility and process environmental monitoring. Responsible for facility cleaning programs
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Senior Qa OfficerSouth Pacific Sera Ltd Nov 2009 - Sep 2018New ZealandProduct Release, Validation, QA Support, QA Training, Document Control, Internal and External Auditing, Customer and Regulatory Support
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Clinical Supplies ManagerNeuren Pharmaceuticals Ltd 2006 - Jun 2010Project manager sourcing and contract managing GMP Clinical trial supplies.Responsible for Development and GMP process scale up of clinical trial manufacture.Author of CMC sections of IND submissionsResponsible for GLP analytical validation.
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Qc Manager, ManufacturingNeuren Pharmaceuticals 2004 - 2006Responsible for sourcing GLP/GMP assay and studies supporting GMP synthesis of Peptides for use in Phase I and II trials.Responsible for sourcing drug substance and drug product IND information
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Staff ScientistNeuren Pharmaceuticals 2001 - 2004Pharmacokinetics of small molecules. Responsible for assay of small compounds using Radio Immune assays and HPLC methodologies to support ongoing preclinical pharmaco-toxicological Studies.
David Batchelor Skills
David Batchelor Education Details
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Paediatrics
Frequently Asked Questions about David Batchelor
What company does David Batchelor work for?
David Batchelor works for South Pacific Sera
What is David Batchelor's role at the current company?
David Batchelor's current role is Development Projects Quality Lead.
What is David Batchelor's email address?
David Batchelor's email address is da****@****pad.org
What schools did David Batchelor attend?
David Batchelor attended University Of Auckland.
What skills is David Batchelor known for?
David Batchelor has skills like Gmp, Glp, Quality System, Clinical Trials, Chemistry, Capa, Auditing, Sop, Regulatory Affairs, Validation, Aseptic Processing, V&v.
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