David O'Halloran has over 15 years of experience in quality assurance and regulatory roles in the pharmaceutical industry. He has held positions such as Director of QA/QC, Quality Assurance Supervisor, and Quality Assurance Associate. He currently works as an independent quality and regulatory consultant helping companies obtain production licenses from Health Canada.

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David O’Halloran CurriculumVitae
Address: 212 Rue Ravel, Vaudreuil-Dorion, QC J7V 0M7
Contact Information: Home: 450-455-4220 Cell: 514-967-8275 e-mail: ohallda1@gmail.com
Summary: Energetic, diligent and friendly with over 15 years’ experience in the
pharmaceutical and biotechnology industry, including over 4 years of
supervisory and management experience and almost 2 years of
consultancy experience.
Objective: To integrate and grow within a company’s Quality Assurance and
Regulatory team. To help implement and maintain the Quality Systems
necessary for the successful development, manufacture and marketing of
products. To help the company adhere to the regulatory requirements
governing the products they manufacture and help in achieving a
company’s corporate goals.
Relevant Work October 2014 to Present Self Employed
Quality and Regulatory Consultant
 Independent consultant for clients wishing to obtain production
licenses from Health Canada to produce pharmaceutical and
natural health products.
 Setting up and implementing Quality Management Systems.
 Writing Standard Operating Procedures.
 Represent clients in communications with Health Canada and
preparation for regulatory audits.
 Advise in the design of facilities from a Quality and Regulatory
perspective ensuring that the production, processing, packaging,
labelling, storage and distribution of pharmaceutical and natural
health products are carried out in accordance with Good
Manufacturing Practices and other regulatory requirements.
September 2010 to August 2012 Vivier Pharma Inc.
Vaudreuil, Quebec
Director, QA/QC
Vivier Pharma Inc. is a skincare product manufacturing company located
near Montreal, Canada with a portfolio of over 50 licensed products
ranging from Natural Health Products, Cosmetic Products and Drug
Products. The
 Managed the Quality Assurance and Regulatory Department
organized the daily activities of the department.
 Aided in New Product Development ensuring the regulatory and
Quality Assurance requirements were met.
 Interpreted and implemented Quality Systems based on regulations
governed by Health Canada (HC), the US Food and Drug
Administration (FDA) and the International Conference for
Harmonisation (ICH), to ensure complete regulatory compliance.

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 Reviewed French and English pre-, and post-production
documentation and printed packaging material including labeling
to ensure compliance with regulatory requirements, and internal
quality standards.
 Performed daily tasks such as finished product and raw material
disposition, including inspection, sampling and testing, managing
the stability program, the handling of product quality related
complaints and adverse reactions.
 Liaised with third party manufacturers and laboratories, including
auditing, review of Quality Agreements, review of Chemical and
Microbiological testing results, etc. to ensure the quality objectives
of the company were met.
 Worked with third party laboratories to validate Chemical and
Microbiological Test Methods.
 Implemented new and updated existing Quality Systems in the
company.
 Ensured the adherence to Good Distribution Practices with regards
to storage condition optimization, inventory control of raw
materials and finished product, transport optimization in relation to
product security and stability.
 Processed, analysed and reported customer complaints / adverse
reactions and returns to ensure that customer satisfaction was
maintained.
 Conducted root cause analysis for all non-conformances reported
and implemented appropriate action plans in response to
investigations, deviations and audits; internal, external or
regulatory.
 Trained new employees and part-time employees on cGMP and the
roles and responsibilities of the Quality and Regulatory Function
within the pharmaceutical industry.
 Ensured all regulatory filings were submitted to the appropriate
regulatory bodies and that the establishment licenses and drug fees
were up to date.
 Have represented Vivier Pharma at the offices of Health Canada’s
Therapeutic Products Directorate in Ottawa in support of drug
product licensing submissions.
July 2008 to September 2010 PharmAthene Inc.
St-Telesphore, Quebec
Quality Assurance Supervisor
PharmAthene Canada Inc. was the Canadian branch of the US
biotechnology company PharmAthene Inc., located close to Montreal,
Canada. The company was commissioned by the US Department of
Defence to develop and provide biological and chemical warfare
countermeasures.
 Supervise the Quality Assurance Team consisting of a Quality
Assurance Specialist, a Document Control Specialist and three
Microbiology Laboratory Technicians.

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 Reviewed, interpreted and approved Microbiological test data.
 Ensure the maintenance of cGMP at the manufacturing site.
 Disposition product at source material level for further processing
and down-stream production.
 Provide cGMP training to all employees at the Production Facility.
 Coach and mentor individuals and team members through training
and performance appraisals.
 Ensured that source materials or product was packaged, stored or
transported in a fashion so as to maintain the integrity and security
of the product.
 Performed audits on companies contracted for the storage and
transport of product.
 Investigated all non-conformances / deviations through root cause
analysis and appropriate CAPA allocation, implementation and
follow through.
 Manage the budgetary allocation to the QA Department.
 Acted as Quality Manager from June 2009 to September 2010 in
the absence of a Quality Manager.
August 2006 to July 2008 PharmAthene Inc.
St-Telesphore, Quebec
Quality Assurance Associate
 Review and aid in the release of batch production records.
 Monitor compliance of GMP regulations in the Production
Facility.
 Aid in the management of the Investigation / Deviation / CAPA
system at the Production Facility.
 Review / Validate QC Chemical and Microbiological test results.
 Aid in the training program at the Production Facility.
 Write and review Standard Operating Procedures.
 Perform Internal and External Audits on Quality Systems.
 Deputize for the Quality Manager.
May 2001 to June 2006 Novartis Ringaskiddy Limited
Cork, Ireland
Laboratory Analyst in QA Department
Novartis Ringaskiddy Limited is a Cork based division of the Swiss
pharmaceutical company Novartis, a large multinational manufacturer of
drug products for a wide range of applications.
 Gained much experience in Analytical Techniques such as GC,
HPLC, Thin Layer Chromatography, IR Spectrophotometry, ROI,
ROE and other wet chemistry techniques.
 Gained extensive knowledge of computer systems including all
Microsoft Office applications, LIMS systems, Q-DIS systems and
Document Management Systems.
 Responsible for purchasing of consumables for the Laboratory.

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 Responsible for the organization of retaining of samples as per
regulatory requirements.
 Aided in the preparation for successful audits carried out by the US
FDA and the Irish Medical Board.
 Carried out internal laboratory audits and also carried out
laboratory safety audits as a Safety Officer for the QA Department.
 Conducted investigations of OOS/OOTtesting results, reported
investigation findings and implemented the resulting action plans.
Third Level Education
1999 – 2001 Cork Institute of Technology Cork, Ireland
Bachelor’s Degree
BSc Analytical and Pharmaceutical Chemistry
Major – Analytical Chemistry and Quality Assurance
1996 – 1998 Cork Institute of Technology Cork, Ireland
National Certificate
National Certificate in Analytical Chemistry
References References available upon request.
Interests and Sailing, Skiing / Snowboarding, Golf
Activities
Voluntary Work Parents Committee: President of parent committee between January
2014 and August 2015 at the daycare where my children attended
Languages English: Fluent in English, both written and spoken.
French: Reasonable level, both written and spoken.
German: Reasonable level, both written and spoken.