Quality Assurance Control

Sharon E. Klinner ** Normandy Place, Oakville, ON

L6K 1R9 Messages 905-***-****

OBJECTIVE: A position that will develop new skills within the Regulatory

Affairs and Quality Division .

EMPLOYMENT HISTORY

03/2006 - 01/2011

GRACECOR, TORONTO, ON

Distributor of OTC colored gelpacks/customized to independent pharmacies &

other retail sectors. Developed territory & establish new & existing

accounts.

07/2004 -12/2005

REGULATORY AFFAIRS SPECIALIST

IOVATE HEALTH SCIENCES INC., MISSISSAUGA, ON

A manufacturer of Dietary Supplements, Foods for US's main market, NHP's &

OTC's for Canada.

OVERVIEW

Manage Site Licensing Applications for US manufacturing sites and Product

Applications for Canada. Provide business strategies/opportunities for New

Product Development/ existing brand marketing line extensions.

ACCOUNTABILITIES

On-going review of Canadian regulations guidelines/policies (CFIA & HPFB)

as well as USFDA changes that may affect the Canadian business,

marketed/marketing NHP products. Revise claims to meet Canadian compliance

and ASC standards with support of published research &/or NHPD published

monographs.

Support QA, Scientific Affairs, Marketing, & other internal areas.

Advise QA in implementing/updating SOPs as well as assess & review Quality

Reports for self care products to support Canadian business.

Support in creating label product summaries (originating from US product

formulations) to label graphics group.

Work with Brand marketing product categories to determine effective claim

statements (proof of evidence from published research /NHP monographs) for

self care; assess product data adequacy for claim statements.

On-going product formulation ingredient reviews for Canadian business.

Track product/site licensing status level; on-going updates to existing &

new databases.

Update claim statements/brochures/labels for existing/new product & line

extensions.

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POWERPOINT PRESENTATIONS (strategies to support the Canadian business

(Prepared for chief execs)

1) PPP - Overview & Agenda - Strategy (based on risk/benefit ratio) to

release product into the marketplace without authorization to sell.

2) PPP - Overview & Agenda - Strategy/ a company case scenario in moving

forward with Clinical Trials for self care (long term plan {goal}).

05/2002-07/2004

REGULATORY COMPLIANCE SPECIALIST - Foods, and NHP's, OTC's & Consumer

Products

INNOVATIVE PRODUCT DEVELOPMENT INC., TORONTO, ON

File NPN and DIN submissions and provide complete label content

for customer products in the Food, NHP and OTC drug markets. In the case of

Food/dietary supplements, the product label(s) content (compliant with

existing regulations) are complete for the graphic artist to fit onto a

specified packaging label. Advise companies on product licensing and GMPs.

12/1994-04/2002

QC/QA NUTRITIONIST/REGULATORY SPECIALIST

SWISS HERBAL REMEDIES LTD., RICHMOND HILL, ON

A manufacturer of more than 600 products that include foods, OTC

drugs and cosmetics. The product line comprises vitamins, minerals,

botanicals & other consumer healthcare distributed products in a variety of

formats. The position requires experience with vitamin, mineral and herbal

products and their application to health care. Assurance of product

/label compliance with governmental regulatory departments: Health Canada,

USFDA.

RESPONSIBILITIES

. Reporting to the Director of Quality Assurance and Product

Development

. Work and communicate with Marketing, R & D, Logistics, Warehouse

and other departments as required

. Liaise with external manufacturers/vendors and contact

laboratories

REGULATORY AFFAIRS

Preparation and submission of product registrations for new/existing

Drug Identification Numbers (DINs).

Notification of DINs with TPD upon issuance from Health Canada;

coordination & preparation of documents for annual drug notification

submission & cost recovery.

Review and prepare labeling content/claims compliant for the Canadian

& US markets.

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QUALITY ASSURANCE

Prepared and executed the Operating Procedure for the On-going

Stability Program of DIN products. Conducted external lab/supplier audits

with the Director of QA during the initial years with the company.

QUALITY CONTROL

Product Release: Confirmation bulk is correct and of good quality

prior to release to packaging. Confirmation of the product's chemical

purity and identification prior to release into the marketplace. This

requires review and verification of house/manufacturer's certificate of

analysis (C of A) and compliance with product master formula,

specifications and label claim.

Stability Program: Coordination of stability testing

specifications and schedules; monitor and report end stability product

results.

Complaints: Investigation and resolution of product related

complaints.

QC Audits: Monthly bottle counts to verify compliance with label

claim on randomly selected products. Liaise with Contact Laboratories:

Preparation and coordination of testing, request for analysis and purchase

order for labs.

Export: Preparation of food/drug export documents and supporting

information (ie. C of A, label sample and product information).

Technical Information: Research and process telecommunicated and written

requests for information (eg. Nutritional, therapeutic use, safety,

efficacy) to consumers, retailers, healthcare professionals, sales

representatives and the branches.

Product Formulator Back-up: Formulation revision for problem

batches in the manufacturing of tablets and hard gelatin capsules.

Skills & Attributes:

. Strong knowledge of Canadian Regulations Guidelines and

Policies

. Strong communication skills

. Self motivated; ability to work independently and as part of a

team

. Knowledge of MS Word, Outlook, Excel, and Power point; will learn

other software's relevant to the business on need basis

Associations

Memberships:

CHFA (Canadian Health Food Association)

CAPRA (Canadian Association of Regulatory Affairs Professionals)

Education:

McGill University, Montreal, Quebec, Bachelor of Science in

Nutrition

Mount St. Vincent University, Halifax, Nova Scotia, Bachelor Science

Degree in Psychology, Minor in Biology

Certificate (PSG) - Pharmaceutical Regulatory Affairs and Quality

Operations

Senaca College - continuing Pharmaceutical Regulatory Affairs

and Quality Operations Certificate

Completed Pharmaceutical Regulatory Affairs and Quality Operations

Continuing Quality Assurance in the Fall 2013

Volunteeer

Oakville Trafalgar Memorial Hospital - Patient Transport (current)

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