Maurice Parlane
Principal/Director

Bachelor of Production Technology (Manufacturing and Industrial) 1st Class Honours
New Zealand Certificate in Engineering (Mechanical)
New Zealand Certificate in Engineering (Electrical) Intermediate

Related Background
Professional engineer with 19 years experience in production and engineering management within the pharmaceutical and biotechnology industries.

Specialist Areas
Production Management, Unit Process Operations, Packing, Engineering, Validation, Specialist Utilities, International Inspection experience.

John Kennerley
Associate

Bachelor of Science ( Science & Management / Computing) [Double major - incomplete]
New Zealand Certificate in Science (Food Science)
SAE International Technology College (Diploma of Multimedia)

Related background
Quality Assurance professional with 20 years experience in quality assurance, laboratory management, regulatory affairs and distribution within the pharmaceutical industry.
- Associate, New Wayz (7 years)
- Consultant, Quality system documentation for large international Software Development Company (3 years)
- Consultant, QA Manager, Senior QA Coordinator, Laboratory Manager, and Laboratory Technician for NZ manufacturing operations of a multi-national pharmaceutical company (13 years)

Specialist Areas
Quality Assurance, Quality Systems, Laboratory operations and management, Training, Documentation,Technical Writing.

Louise Dibley
Associate

Bachelor of Production Technology (Manufacturing)
Business Studies Diploma (Strategic Management & Finance)
Quality Diploma (Lead Audit)

Related background
Industrial Engineer with 16 years experience in commercial management and technical operations within the international pharmaceutical industry.
- Senior Consultant, New Wayz (2 years)
- Global Logistics, Strategy and Product Sourcing Manager (144 sites) for Corporate Division of UK based multi-national pharmaceutical company (5 years)
- Regional Technical Manager (24 sites) for multi-national pharmaceutical company (3 years)
- Asia-Pacific Technical Manager, Technical Specialist (Packaging) and Project Engineer for NZ manufacturing operation of multi-national pharmaceutical company (6 years)

Specialist Areas
Project Management, Sourcing, Technical Transfer, Supplier Management, Packaging, Quality Assurance..

Mark Balchin
Senior Consultant

Bachelor of Technology (Biotechnology and Bioprocess Engineer)

Related Background
Validation Engineer with 13 years experience in operational support within the pharmaceutical and associated industry.
- Senior Consultant, New Wayz (2 years)
- Senior Validation Engineer and Validation Engineer at 2 UK sites for a multi-national pharmaceutical company (5 years)
- Validation and Process Engineer for NZ based Biopharmaceuticals manufacturer (4 years)
- Bioprocess Engineer for NZ manufacturing company (2 years)

Specialist Areas
Bioprocessing, Fermentation, Aseptic Processing, Sterilisation, FDA Inspection experience.

Clive Edwards
Senior Consultant

Bachelor of Science
Post Grad Software Engineering and Object Oriented Software Development
NZQA (Lead Auditor)

Related Background
Over 20 years experience in the pharmaceutical industry working in both the manufacturing and regulatory fields.
- Auditor for Medsafe, NZ Ministry of Health for compliance with the Codes of GMP (4 years)
- Computer Systems Quality Consultant, Automated Systems Project Manager, Instrumentation Manager in UK to multi- national pharmaceutical company (19 years)

Specialist Areas
Auditing, Quality Assurance, International Inspection Experience, Crtical Utilities & Production Engineering, Automated Computer Systems, Validation, and Project Management.

John Meffin
Consultant

Bachelor of Pharmacy
Registered Pharmacist (NZ and UK)

Related Background
30 years experience in management, production and laboratory operations within the pharmaceutical industry.
- Consultant, New Wayz (1 year)
- Production and IT Manager for NZ operation of a multi-national pharmaceutical company (12 years)
- Roles as Operations and Factory Manager for NZ Pharmaceutical companies (10 years)
- Pharmacist, QA and technical roles with UK Pharmaceutical companies (7 years)

Specialist Areas
Laboratory Operations, COTS Software Assurance, Manufacturing Operations Training.

Barbara Dodd
Consultant

New Zealand Certificate in Science (Biochemistry and Microbiology)

Related Background
18 years experience in quality assurance and quality control within the pharmaceutical industry.
- Consultant, New Wayz (1 year)
- QA Manager, QA Officer, QC Officer, Senior Analyst and Laboratory Analyst, for NZ based multi-national pharmaceutical manufacturing operations (17 years)

Specialist Areas
Quality Management, Quality Systems, Documentation, Quality Control, Technical Writing.

Robert Keenan
Senior Consultant

Related Background
Technical Specialist with 19 years experience in cGMP compliance, QA/QC, validation, engineering and construction management within the pharmaceutical, biotechnology and associated industries.
- Project and Quality Assurance Co-ordinator for large capital project at Singapore secondary manufacturing site for a multi-national pharmaceutical company (2 years)
- Director, Regulatory Compliance and Validation for Singapore based consulting practice (3 years)
- Validation Manager for Singapore office of multi-disciplinary consulting company (3 years)
- Lead Validation Specialist at a large UK manufacturing site for a multi-national pharmaceutical company (1 year)
-Validation and Lead Validation specialist for a UK based multi-national construction management company (10 years)

Specialist Areas
QA/QC, cGMP design, Qualification and Commissioning, Training, Project Management, EU and FDA Inspection experience.