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Quality Systems & Compliance Specialist in Oakville at Innomar Strategies

Date Posted: 12/3/2018

Job Snapshot

Job Description

POSITION SUMMARY:
Under the general direction of the QA Director, the Senior Quality Systems and Compliance Coordinator supports the implementation and continuous improvements of Innomar’s Quality Systems by primarily being accountable for the quality systems and compliance verification activities (monitoring of external and internal audits and CAPAs, quality metrics reporting, etc.) and the management of the electronic quality management system (eQMS).


PRIMARY DUTIES AND RESPONSIBILITIES:
  • Provide leadership to quality systems and compliance activities at Innomar, including monitoring of deviations, CAPAs, change controls, external audits and continuous quality process improvements.
  • Responsible for the management and administration of the electronic quality management system (eQMS), including: management of user profiles and role assignments; creation and maintenance of folder/vaults for controlled documents, training courses, quality event processes and forms; and providing support and consultation on the creation, periodic review, revision and obsolescence of controlled documents.
  • Lead corporate training initiatives relevant to quality systems.
  • Track progress of quality systems and compliance activities and follow up with QA Managers and issue owners (business unit heads) to ensure completeness and suitability prior to timely file closure.
  • Utilize structured, disciplined, and data-oriented problem-solving techniques for quality issues including but not limited to: identifying quality issues, performing formal investigations, conducting root cause analyses, writing and/or consulting on corrective action and preventive action plans.
  • Identify gaps/opportunities and develop appropriate corrective/preventive action plans to drive improvements to the quality system, while ensuring timely identification and escalation of critical quality issues to senior QA management.
  • Coordinate with QA management and business unit heads in addressing quality issues and in the implementation of identified new/updated processes and tools.
  • Lead in risk assessments for deviations and system inadequacies, in conjunction with QA management.
  • Develop quality KPIs and scorecards pertinent to the relevant Innomar business units, as well as maintains and reports accurate and timely quality system metrics in collaboration with QA Managers.
  • Works with QA Managers to identify quality trends and prepare periodic Quality Management Reports (QMRs) for review by business unit management.
  • Recommend organizational process improvement initiatives based on identified trends and key performance quality metrics.
  • Assist the QA Managers in the preparation, hosting and follow-up activities pertaining to client audits and regulatory inspections.
  • Facilitate responses and CAPAs resulting from client audits and regulatory inspections, in collaboration with the QA Managers.
  • Ensures adequate and timely closure of CAPAs with supporting documented evidence in accordance with Innomar SOPs and processes.
  • Coordinates with QA management in the scheduling of vendor/supplier qualification audits, as well as in the follow-up of responses and closure of internal audits.
  • As assigned by the QA Director, conducts internal process/system audits as well as vendor/supplier audits.
  • As assigned by the QA Director, review and approve audit reports submitted by QA auditors for content, format, regulatory risks, and compliance with applicable standards.
  • Provide assistance to the QA Managers and QA Director as required.
  • Work under challenging deadlines and be accountable for completing work within specified time periods.
  • Performs other projects as assigned


Job Requirements

EXPERIENCE AND EDUCATIONAL REQUIREMENTS:
  • Bachelor's degree, minimum (preferably in life sciences or scientific discipline).
  • Minimum of 10 years’ experience in conducting internal and vendor audits as well as hosting external/client audits and regulatory inspections.
  • Experience managing Quality Systems required, specifically in SOP management, change controls, deviation investigations and CAPAs.
  • Applied knowledge of pharmaceutical Good Manufacturing Practices or device Quality System Regulations or ISO quality standards.

MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:
  • Working knowledge of Good Manufacturing Practices (GMP) or other Good Regulated Practices (GxP’s) as they relate to Innomar activities.
  • Strong analytical thinking
  • Superior quality of work and attention to detail.
  • High customer-focus; strives to support others to succeed
  • Pronounced quality-focus
  • Excellent networker and team player, peoples person
  • Strong leadership without formal authority, speak up mentality, ability to influence and achieve results in a matrix organization
  • Efficient in compiling, managing and interpreting data from various sources (e.g. from audits, complaints, non-conformances, etc.).
  • Advanced proficiency in the use of computerized systems to effectively administer the specialized electronic quality management system (eQMS) applications, as well as efficiently utilize common office applications (e.g., Outlook, PowerPoint, Word, Excel, Visio and Adobe Acrobat).
  • Effective organizational, time-management and prioritization skills.
  • Ability to work independently.
  • Demonstrated ability to meet tight deadlines in an environment of competing priorities.
  • Excellent interpersonal, written and verbal communication skills.
  • Refined strategic, collaboration and presentation skills.
  • Team player who respects all functional levels internally and externally.
  • Strong self-motivation and ability to work under limited supervision