Quality Compliance Specialist – Complaints – BILINGUAL

Job title: Quality Compliance Specialist – Complaints – BILINGUAL

Job description: Quality Specialist Compliance – Complaints

Zany Consulting Group

This is a remote position – Candidate can either work from Ontario or Quebec – Bilingual in French and English is a must.

Build a better career with Zany Consulting Group

Serving customers and the community starts with the most talented people doing their very best work. That is precisely what we have at Zany Consulting Group, a leading Professional Services Consulting firm. Zany Consulting Group is seeking exceptionally driven, experienced Quality Specialist Compliance – Complaints to undertake projects for one of our clients in Quebec.

In this role:

Contribute to establishing and maintaining high quality and compliance status of all products handled by our client to meet all Canadian cGMP regulations, as well as corporate requirements.

Responsibilities and Duties for the role:

• Coordinates with QA Coordination Call Center to obtain essential information required to document technical complaints
• Provides support to QA Coordination Call Center to meet the needs of the complainant
• Identifies and confirms inquiries as product technical complaints
• Evaluates complaints for severity and risk to public safety.
• Notifies interested departments (eg. Country Quality Head, manufacturing site QA,) upon receipt of critical complaints.
• Monitors and tracks sample receipt from complaints.
• Ensures complaints are reviewed and processed within a timely fashion
• Prioritizes complaints for data entry and processing into the global database
• Utilizes the customer service database to oversee complaint identification and processing
• Interacts with both internal and external manufacturing sites regarding technical complaints and their associated investigations
• Performs QC Checks
• Understands Health Canada complaint regulations for drug products and medical devices
• Performs file review and administrative closure for individual complaints
• Produces trending reports
• Monitors open complaint activity for each manufacturing site
• Interacts with Customer Service, Medical Information, Pharmacovigilance and other company departments/associates regarding the identification and evaluation of technical complaints
• Identifies and reports adverse events within one business day to Pharmacovigilance
• Provides complaint support to other company departments including Customer Service, Medical Information, Pharmacovigilance, Sales Associates, Regulatory, Commercial Operations, Legal, and Risk Management
• Participates on ad-hoc teams regarding product-specific complaint issues
• Supports during the regulatory, third party, and internal audits
• Understands product specific information regarding common product complaints
• Understands department process flows and complaint databases
• Coordinates feedback to customers regarding complaint investigations via QA Coordination Call Center
• Other QA duties, as assigned

Key requirements for the job:

EDUCATION: B.Sc. in Chemistry, Biology or related sciences *

EXPERIENCE: Minimum of 3 to 5 years of related experience within the pharmaceutical industry.

Skills and Qualifications:

• Strong Verbal and Written Communication Skills
• Problem Solving Skills
• Adept at Attention to Detail
• Strong understanding of Good Documentation Practices
• Good organizational skills
• Analytical skills
• Self-motivated/directed
• Computer literate-proficient in use of word processors. Must be able to understand and utilize complaint database software and reporting tools
• Knowledge of cGMPs and Health Canada regulations regarding drugs, medical devices, combination products, biologics and natural health products
• Project and Time Management Skills
• Interpersonal skills-must be proactive, personable, flexible, team-oriented
• Customer Service Skills
• Ability to multitask in a highly stressful environment
• Ability to operate in a constantly changing environment

LANGUAGES: French and English written and spoken is a must

TRAVEL: Occasional

COMPUTER KNOWLEDGE: SAP, MS Office, Adobe Suite

This job is remote

Zany Consulting Group strives to help our customers achieve greater productivity, profitability, and quality work through a team of experienced consultants in the pharmaceutical industry. When you join our team, you will receive rewards and recognition for your contributions, training and professional development opportunities. If you are inspired to learn, take risks, and succeed as a team, you can build a better career at Zany Consulting Group.

Equal Opportunity Statement: All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity.

Job Type: Contract – Full time

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Company: Zany Consulting Group

Expected salary:

Location: Toronto, ON

Job date: Wed, 02 Jun 2021 05:19:02 GMT