Compliance Specialist

April 23 2019
Industries Pharmaceutical, Biotechnology
Categories Production, Operations, Quality, Safety, Pharma, Biotech, Sciences, R&D, Pharmaceutical, Quality - Test - Inspection, Quality assurance and control - Validation
Kirkland, QC

Jubilant DraxImage, a subsidiary of Jubilant Pharma Holdings Inc, is currently recruiting for a Compliance Specialist position to join our growing team! 

What can we offer?

A culture that values opportunity for professional growth and development,highly competitive base pay, comprehensive medical, dental and disability benefits programs, group retirement savings program, health and wellness programs.
 

Jubilant DraxImage Inc. is a rapidly growing company with offices in Kirkland, QC and Yardley, PA. A global leader in the development of radiopharmaceuticals and state-of-the-art technologies, we are continuously seeking high caliber professionals to join our team. Jubilant DraxImage is a proud member of the Jubilant Pharma family. For more information, visit www.draximage.com

We will, with the utmost care for the environment and society, continue to enhance value for our customers and stakeholders by providing innovative products and economically efficient solutions' through growth, cost effectiveness and wise investment of resources.

If you're up for a rewarding challenge, we invite you to take the first step and apply today!

Jubilant Pharma Holdings Inc and all our subsidiaries proudly embraces diversity in our workforce. Our goal is to have a workforce as diverse as the patients and clients we serve. We have an inclusive environment where our employees can thrive and where our differences are welcomed. By welcoming our differences, we create products that are beneficial for our patients, clients, and overall human health.

Summary

The Compliance Specialist will be responsible for ensuring cGMP appropriateness of operations and continuous improvement activities are established, monitored and maintained to ensure compliance with all applicable regulations, SOPs and company.

Responsabilities

  • Maintains knowledge and understanding of current industry practices to ensure Subject Matter Experts are aware of industry improvements and compliance risks;
  • Conducts gap assessments to assess compliance in regards to HC, FDA, ISO, ICH, and regulations impacting cGMP/ ISO operations, as well as for updates in new Regulatory requirements;
  • Analyzing key performance indicators to highlight areas of improvement;
  • Ensures that the Management team is aware of the Improvement requirements and builds an integrated plan that delivers both the needed results and the growth in capability (skills and culture) for sustaining Continuous Improvement;
  • Leads Compliance continuous improvement projects (based on trends, internal audit observations, etc.) that can be leveraged across departments, functions, and product families.
  • Participates in Internal Audits and Site Inspection Readiness activities
  • New Product Introduction: Compliance representative in new product introduction activities and document approval
  • In collaboration with Validation, review and approve validation plans and protocols / reports;
  • Participates in product quality complaint investigations as needed to address problems and assist in resolution;
  • Participates in Internal Audits and Site Inspection Readiness activities
  • Participates in the maintenance of the Annual Product Quality System (writing and adherence to established schedule);
  • Meeting global KPIs and metrics;
  • Performs any other tasks assigned by Management.
  • Participates in External Audit activities / Quality Agreements, as needed.

Requirements

  • Bachelors Degree in a scientific discipline and 6 years of related experience or Masters Degree in a scientific discipline and 2 years of related experience
  • Thorough knowledge of cGMP (Pharma) and ISO regulations (Medical Device);
  • Thorough knowledge in FDA and Health Canada Regulations
  • Experience with FDA or Health Canada inspections
  • Self-starter / able to function under minimal supervision
  • Good leadership skills / 'take charge' attitude
  • Tactful communication and interpersonal skills
  • Ability to oversee the 'big picture', yet diligent to details
  • Creative talents
  • Capacity to multi-task a number of issues at a time
  • Good analytical skills
  • Excellent organization and planning skills
  • Ability to understand scientific issues in order to help the planning of the work
  • Software proficient, including MS Project
  • Written and spoken English and French  
Apply now!

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