Quality Assurance - Quality Compliance Coordinator

Westerkirk•Toronto, ON

2d•CA$60,000 - CA$70,000•Onsite

About The Position

This role is responsible for supporting the Compliance activities within the Quality group and across Cosmetica. The person in the role will enforce quality management systems by training, conducting regular internal audits, document control, records review, tracking status of corrective/preventive actions while working closely with other departments. This role is also responsible for hosting and managing external audits and supporting the Supplier Management program.

Requirements

Bachelor’s degree in science; Chemistry, Chemical Engineering, Biochemistry or any related science
Minimum 3 - 5 years’ experience in quality assurance, quality system compliance in a GMP environment; with extensive knowledge of government regulations; global market requirements / regulations; quality standards recognized globally.
Demonstrated proficiency in quality management software & tools, with relevant experience in implementation of electronic quality management system; with cognitive ability to learn new software
Strong knowledge and application of cGMPs in similar industry, pharmaceutical, cosmetics, food, and or natural health manufacturing environment,
Demonstrated comprehension of course design and delivery of training. Proficiency in MS Office applications & tools
Excellent interpersonal skills: communication, presentation, and facilitation skills; must have experience in conducting training and performing audits
Highly organized with the ability to work in a fast-paced environment; Result-oriented and self-motivated person.

Responsibilities

Perform all compliance-related activities required in implementation, upgrade, and maintenance of electronic QMS modules, such as document control, training management, change control management, NCR, CAPA, and other modules in QMS platform
Review drafted and approved documents in QMS for compliance to Documentation Manual process and GMP requirements
Release all approved documents in QMS before the effective date, to allow employee training prior to implementation
Coordinates completion of steps involved in managing change controls in QMS with respective stakeholders
Coordinate training requirements/needs with other stakeholders; assist in creating document training profiles for the role in QMS; administer in-class document training when required
Work with stakeholders to ensure that course content, learning objectives, and supporting materials accurately reflect current GMP policies, company processes, and current regulatory standards
Develop an effective training programs (classroom or e-learning based) that are focused on intended audience, when needed; create necessary supporting materials to complete GMP training requirements (e.g. Quiz, GMP Refresher course slides, training supplements)
Conducts the annual GMP training for all employees and handles the GMP orientation for new employees
Tracks training status in QMS and coordinate with area Manager, if any concern impacting completion by due date; may assist in evaluation of training gaps in other departments and work with respective area management to close gaps
Periodically review audit/inspection observations, OOS, deviations, and trends and modify the GMP training program accordingly.
Responsible to manage internal audits (self-inspection program); prepares Self Inspection plan and audit schedule for the whole year; perform inspection of the facility to verify GMP compliance; coordinate action plans to concerned individuals based on audit findings.
Responsible for hosting and managing external audits; including but not limited to regulatory audits (FDA & Health Canada), third-party certification audit (ISO22716), and client/customer audits
Track audit results and actions taken in regular basis; make follow-ups
Support quality compliance goals and objectives; reports KPI results in regular basis
Manage supplier assessment & qualification, supplier audits, and certification program
Responsible to monitor the performance of RMS Temperature Monitoring System in the whole facility (both Warden and Ashtonbee locations); coordinate necessary actions with respective active users
Assists in reviewing validation protocols for equipment qualifications, cleaning validation, and temperature mapping; prepares addendum or amendment, when needed
Perform other duties as required to support QA activities including review of batch records, generation of CoAs root cause analysis, and client interactions.