Quality Assurance - Quality Compliance Coordinator
at COSMETICA LABORATORIES INC
Toronto, ON, Canada -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 24 Dec, 2024 | Not Specified | 28 Sep, 2024 | 3 year(s) or above | Pharmaceutical Manufacturing,Training,Chemistry,Biochemistry,Interpersonal Skills,Regulations,Chemical Engineering | No | No |
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Description:
Quality Compliance Coordinator
Full-Time, Permanent
Onsite – Scarborough ON
Purpose
The Quality Compliance and Training Coordinator is responsible for managing Quality Management System (QMS), planning, development and delivery of GMP and compliance training programs; to ensure GMP guidelines are implemented, and quality improvement programs are enforced by training, supporting regular internal audits.
SKILLS, EXPERIENCE AND EDUCATION:
- Bachelor’ degree in Science; Chemistry, Chemical Engineering, Biochemistry or any related science
- Minimum of 3-5 years’ experience in quality assurance or in a GMP environment
- Strong knowledge and application of cGMPs/GMPs in a pharmaceutical manufacturing and or QA/QC environment
- Excellent interpersonal skills: communication, presentation, and facilitation skills; must have experience in conducting training and hosting audits with knowledge of government regulations; global market requirements / regulations; quality standards recognized globally
- Demonstrated ability to work in partnership with and build strong links to all areas of the business. Ability to provide feedback and coaching to others
- Demonstrated comprehension of course design and delivery of training. Proficiency in MS Office applications, ability to learn new software as required
- Highly organized with the ability to work in a fast-paced environment; Result-oriented and self-motivated person.
Interested candidates are welcome to submit their resume and cover letter directly to this posting by Monday September 23, 2024
Responsibilities:
- Manages all compliance-related activities such as document control, training management, document control, non-conformance management, change control management, and Corrective and Preventative Action (CAPA) modules as well activities required in effective implementation and sustainability of Plant Hygiene program
- Establish, monitor and enhance training programs, and standards to ensure compliance with regulations including GMP training.
- Register new employees in QMS and make QMS training module available to those who require access.
- Review of document change request, document control review of document, awaiting release of document and verification of Implementation of actions.
- Design, implement and deliver GMP and Compliance training programs in coordination with stakeholders; may include other Quality Training Program for staff to promote quality consciousness. Maintains training records and coordinate training requirements/needs.
- Effectively work with stakeholders at the site to ensure that course content, learning objectives, and supporting materials accurately reflect current GMP policies, company processes, and current regulatory standards
- Writes, reviews and approves SOPs according to GMP requirements, act as SOP Controller and ensures all SOPs are current; updated and distributed accordingly. Makes sure that concerned people are trained on current standard operating procedures
- Maintain all necessary training records and documentation.
- Monitor training gaps for different departments and work with respective management to close gaps
- Supports regulatory or customer audits.
- Prepares compliance and training scorecard and KPIs tracking reports
- Other duties as required
REQUIREMENT SUMMARY
Min:3.0Max:5.0 year(s)
Pharmaceuticals
Pharma / Biotech / Healthcare / Medical / R&D
Clinical Pharmacy
Graduate
Science chemistry chemical engineering biochemistry or any related science
Proficient
1
Toronto, ON, Canada