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David Batchelor is listed as Development Projects Quality Specialist at South Pacific Sera, based in Auckland, New Zealand. AeroLeads shows a work email signal at thebatchelorpad.org and a matched LinkedIn profile for David Batchelor.
David Batchelor previously worked as Team Leader QA/QC operation at South Pacific Sera Limited and Acting Quality Manager at South Pacific Sera Limited. David Batchelor holds Doctor Of Philosophy (Phd), Paediatrics from University Of Auckland.
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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
Listed skills include Gmp, Glp, Quality System, Clinical Trials, and 14 others.
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Working 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
2IC 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
Timaru, New Zealand
Company 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
New Zealand
Product Release, Validation, QA Support, QA Training, Document Control, Internal and External Auditing, Customer and Regulatory Support
Project 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.
Responsible 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
Pharmacokinetics of small molecules. Responsible for assay of small compounds using Radio Immune assays and HPLC methodologies to support ongoing preclinical pharmaco-toxicological Studies.
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David Batchelor works for South Pacific Sera.
David Batchelor is listed as Development Projects Quality Specialist at South Pacific Sera.
AeroLeads has found 1 work email signal at @thebatchelorpad.org for David Batchelor at South Pacific Sera.
David Batchelor is based in Auckland, New Zealand while working with South Pacific Sera.
David Batchelor has worked for South Pacific Sera, South Pacific Sera Limited, South Pacific Sera Ltd, Neuren Pharmaceuticals Ltd, and Neuren Pharmaceuticals.
You can use AeroLeads to view verified contact signals for David Batchelor at South Pacific Sera, including work email, phone, and LinkedIn data when available.
David Batchelor holds Doctor Of Philosophy (Phd), Paediatrics from University Of Auckland.
David Batchelor is listed with skills including Gmp, Glp, Quality System, Clinical Trials, Chemistry, Capa, Auditing, and Sop.
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