Quality Assurance Gmp Lead - Gloucester, Canada - Ontario Medical Supply

Ontario Medical Supply

Verified Company

Gloucester, Canada

3 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

The purpose of this position is to assist with and coordinate activities pertaining to Quality, Safety and Risk Management.

This position will also assist in providing education to staff in ensuring that quality, safety and risk are integrated within the daily activities across the organization.

Job Title:
Quality Assurance GMP Lead

Location:
Ontario Medical Supply (OMS) - Ottawa, ON

Reports to:
Quality Control Senior Manager

No

of Positions:
1

ATR:4390

Type:
Full time

Salary:
Salaried, commensurate with experience

Benefits:

Comprehensive benefits package including health and dental insurance, disability & life insurance as well as opportunity to participate in a group registered retirement savings plan.

Responsibilities:

Experienced with hosting regulatory GMP inspections (Health Canada
DEL and MDEL) and CAPA responses/Remediation Plans
In depth knowledge of regulatory requirements, i.e., GMP, Health Canada and experience with GMP documentation review (Wholesaling Pharmaceutical Drugs & Distribution of Medical Devices)
Experienced in hosting customer audits and certification audits (e.g., ISO 9001)
Lead Quality team to establish and maintain the Quality Management System
GMP team lead leads all GMP compliance activities as per the Health Canada requirements
Manage GMP Warehouse activities for the distribution of Pharmaceutical Drugs (DEL) and Medical Devices (MDEL)
Manages customer complaints and incident investigations
Develop and implement Standard Operating Procedures (SOPs)
Maintain regulatory licenses (MDEL, DEL, Controlled Substances)
Effectively manage workforce including training, coaching and discipline
Develop and manage departmental goals in support of company objectives
Ensure company policies and procedures are always followed
Completes various quality reporting tasks including trend analysis (KPIs)
Other duties as required

Skills:

Strong communication skills, both verbal and written
Able to manage multiple projects within tight deadlines
Initiative and selfmotivation
High degree of analytical and observational skills

Qualifications:

B.Sc. in Chemistry, Biology or related sciences from a university or formal certificate of equivalency
Extensive knowledge of Canadian Good Manufacturing Practices (GMPs)
35 years working experience in a Health Canada Regulated Environment
Knowledge of relevant legislation, standards and ISO requirements is an asset

Benefits: