David Batchelor

David Batchelor Email and Phone Number

Development Projects Quality Lead @
David Batchelor's Location
Auckland, Auckland, New Zealand, New Zealand
David Batchelor's Contact Details

David Batchelor work email

David Batchelor personal email

n/a
About David Batchelor

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

David Batchelor's Current Company Details
South Pacific Sera

South Pacific Sera

Development Projects Quality Lead
David Batchelor Work Experience Details
  • South Pacific Sera
    Development Projects Quality Specialist
    South Pacific Sera Mar 2022 - Present
    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
  • South Pacific Sera Limited
    Team Leader Qa/Qc Operation
    South Pacific Sera Limited Nov 2019 - Feb 2022
    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
  • South Pacific Sera Limited
    Acting Quality Manager
    South Pacific Sera Limited Sep 2018 - Oct 2019
    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
  • South Pacific Sera Ltd
    Senior Qa Officer
    South Pacific Sera Ltd Nov 2009 - Sep 2018
    New Zealand
    Product Release, Validation, QA Support, QA Training, Document Control, Internal and External Auditing, Customer and Regulatory Support
  • Neuren Pharmaceuticals Ltd
    Clinical Supplies Manager
    Neuren Pharmaceuticals Ltd 2006 - Jun 2010
    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.
  • Neuren Pharmaceuticals
    Qc Manager, Manufacturing
    Neuren Pharmaceuticals 2004 - 2006
    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
  • Neuren Pharmaceuticals
    Staff Scientist
    Neuren Pharmaceuticals 2001 - 2004
    Pharmacokinetics 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

Gmp Glp Quality System Clinical Trials Chemistry Capa Auditing Sop Regulatory Affairs Validation Aseptic Processing V&v Quality Assurance Hplc Pharmaceutical Industry Biotechnology Life Sciences Technology Transfer

David Batchelor Education Details

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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