Compliance Specialist, Quality Assurance

November 12 2021
Industries Healthcare, social assistance
Categories Production, Operations, Quality, Safety, Pharma, Biotech, Sciences, R&D, Quality assurance and control, Validation, Research and development
Montreal, QC

Primary Scope

The Montreal Health Innovations Coordinating Center (MHICC) is looking for a full time Compliance Specialist, Quality Assurance.  The incumbent in this role is responsible for standard operating procedures (SOP) management, training and ensures compliance with the protocols, SOPs, Good Clinical Practices (GCP) and applicable international regulations/guidelines through audits.

About Montreal Health Innovations Coordinating Center (MHICC) – Montreal Heart Institute (MHI)

The Montreal Health Innovations Coordinating Center (MHICC) is a full service small to mid-sized academic contract research organization focused on Phase II and III multicenter and multinational clinical trials. Our main goal is to establish partnerships with our customers, in order to ensure a successful implementation of their project while respecting the budget, timelines and always ensuring the highest standards of quality.

The MHICC is an integral part of the Montreal Heart Institute (MHI) is an ultra-specialized cardiology care. For some people, the MHI is synonymous with cutting-edge technology; for others, it is an internationally recognized institution that places a heavy accent on teamwork; for others still, the MHI is a warm and welcoming environment. For all employees, it is a unique workplace where they can find their own rhythm. Whether you like the passionate and dynamic challenges of cardiology, a fun and friendly atmosphere charged with excitement, or even a steadfast workplace that lets you easily balance professional and family life, the MHI is a place where you can meet your career goals.

Key Responsibilities

Under the supervision of Head, Quality Assurance the candidate assumes the following responsibilities:

  • Conducts internal and external audits
  • Reports audit findings, and prepares and distributes audit report
  • Collaborates with auditees to develop  corrective and preventive actions
  • Reviews, approves and assesses the efficiency of corrective and preventive actions
  • Manages post-audit activities and follow-up on any necessary corrective and preventive actions
  • Assists with the preparation, coordination and management of regulatory inspections and client audits
  • Provide guidance to internal clients to ensure compliance with GCP and quality requirements 
  • Maintains QA files and records including but not limited to training records, internal and external audits, deviations, and document control records.
  • Interprets applicable standards and objectively makes decisions
  • Develops training materials and performs training (orientation of new employees, QA SOP, regulatory, etc.)
  • Develops and maintains SOPs
  • Maintains and performs archiving of documentation
  • Reviews and approves change control documentation
  • Provides administrative and clerical support to the study team and to the MHICC, as required

QUALIFICATIONS

  • Bachelor in Science or a related field  (compulsory)
  • Perfectly bilingual spoken and written French / English (compulsory and tests to be passed)
  • Relevant experience (5 years) in quality assurance in the pharmaceutical, biotechnology industry or in a contract research organization (an asset);
  • Attentive to details
  • Effective organization, communication and team orientation skills.
  • Excellent problem solving, decision making and negotiation skills.
  • Strong interpersonal skills and ability to initiate assigned tasks and work independently
  • Skills of the MS Office suite (Word, Excel, and PowerPoint) intermediate level (tests to pass for Word & Excel)

WORK CONDITIONS

  • 35 hours weekly base
  • Telework and flexible work schedule
  • 4 weeks' vacation after one year
  • 13 statutory holidays
  • Defined retirement benefits (REGOP)
  • Group insurance
  • 9.6 day off sick days

Interested candidates are requested to send their applications, no later than December 10h, 2021, to the attention of Ms. Konstantina Panaritis at ***********.*********@*****.***

 

Visit our websites: www.icm-mhi.org & www.mhicc.org

We offer equal employment opportunities to all.

Only people selected for an interview will be contacted.

Apply now!

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