Overview

AmerisourceBergen Quality Assurance/Regulatory Affairs Specialist Full Time in Milton, ON

AmerisourceBergen

Branch Milton ON CA

Position:
Quality Assurance/Regulatory Affairs Specialist
Location:
Milton, ON

Ensuring Innomar GMP facilities operate and are in compliance with Good. Direct consumer or pharmaceutical regulatory experience….

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Description

POSITION

SUMMARY:
Under the general direction of the QA/RA Manager,
primarily responsible for ensuring that Innomar operates and is in compliance
with Good Manufacturing Practices (GMP), Narcotics, Medical Devices and Natural
Health Products regulations/requirements as set out by Health Canada and
Innomar Corporate policies. This is an individual contributor position
responsible for the timely filing and maintenance of Innomar’s Health Canada
licenses, for coordinating with clients and foreign sites, and for reviewing
and/or preparing regulatory and QA documents associated with foreign sites and
products listed in Innomar’s licenses.

This position is categorized as
compliance critical and, as such, requires and is assigned specific
responsibility for ensuring continual and proper compliance with all
regulatory, corporate and division requirements.

PRIMARY

DUTIES AND RESPONSIBILITIES:
·

Maintenance and timely completion of
quality and regulatory documents to support regulatory compliance.

·

Initiate documentation required for
Health Canada license applications/ amendments/ renewals.

·

Maintain a tracking system for
applicable Health Canada license requirements and ensuring that all Innomar
licenses are up-to-date and that required renewals/amendments are submitted to
Health Canada in a timely manner.

·

Coordinate with clients and/or
foreign sites in the compilation of complete GMP Quality documents to support
the importation of assigned products.

·

Perform timely review and assessment
of documents received from clients/foreign sites, including but not limited to,
manufacturing and packaging records, Certificates of Analysis, Certificates of
Manufacture, stability reports and other product release documents.

·

Maintain and review in-house and
client-based quality documents like APQR, stability reports, equipment and
facility qualification/validation protocols and reports, product label,
temperature study etc.

·

Investigate and document any
discrepancy recorded during product handling and made product disposition
decisions in conjunction with client.

·

Develop and/or complete quality and
regulatory documents to ensure appropriate documents are maintained by Innomar
as required by regulations, client agreements and internal procedures.

·

Implement an effective system for
maintaining copies of documents received from clients/foreign sites as well as
those submitted to Health Canada, allowing ease of location and retrieval of
records.

·

Perform quality and regulatory
reviews and oversight on imported products as assigned.

·

Support the QA department in
ensuring Innomar GMP facilities operate and are in compliance with Good
Manufacturing Practices and applicable Health Canada regulations and corporate
policies.

·

Assist in the development and
implementation of regulatory affairs policies and procedures to ensure that
regulatory compliance is maintained or enhanced.

·

Assist in product launch activities
as assigned.

·

Work with other functional areas to
resolve issues related to information for regulatory submissions.

·

Manage DEL amendment process to
ensure timely addition of foreign sites to Innomar’s license.

·

Provide support during regulatory
inspections by Health Canada and during quality audits by customers and third
party auditors.

·

Provide regulatory and Quality
Assurance guidance and support to potential new clients as assigned.

·

Provide assistance to the QA/RA
Manager and Director, Quality Assurance as required.

·

Performs other projects as assigned

Qualifications

EXPERIENCE AND EDUCATIONAL REQUIREMENTS:
·

Bachelor’s degree required (preferably in scientific discipline)

·

Minimum of 3 years’ experience in Regulatory Affairs and/or GMP Quality Assurance

·

Direct consumer or pharmaceutical regulatory experience

·

Regulatory Affairs or Quality Assurance Certification as asset

MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:
·

Must have full and complete knowledge of the Good Manufacturing Practices and applicable Health Canada regulations and guidelines (i.e., Drugs, Medical Devices, Natural Health Products, Narcotics, etc.) as they relate to Innomar activities.

·

High level of organization and attention to detail.

·

Effective time-management and prioritization skills.

·

Motivated and self-starter demonstrating a solution-orientated working style.

·

Efficient in compiling, managing and interpreting data from various sources (e.g. from clients and their affiliates).

·

Team player who respects all functional levels internally and externally.

·

Refined strategic, collaboration and presentation skills.

·

Effective interpersonal, written and verbal communication skills.

·

Knowledge of computers to effectively utilize common office applications (e.g., Outlook, PowerPoint, Word, Excel and Adobe Acrobat).

Organization

:

Canada

Job

:

Information Technology Jobs

Schedule

:

Full-time

Primary Location

:

Canada-Ontario-Milton

or proceed with Standard Application Form.

Employment Type: Full Time
Location: Milton, ON, CA
Posted on: 2017-04-02
Posted by: