Quality Assurance - Quality Compliance Coordinator

at  COSMETICA LABORATORIES INC

Toronto, ON, Canada -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate24 Dec, 2024Not Specified28 Sep, 20243 year(s) or abovePharmaceutical Manufacturing,Training,Chemistry,Biochemistry,Interpersonal Skills,Regulations,Chemical EngineeringNoNo
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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