Montréal - Quebec (QC),
The Compliance Associate’s primary purpose is to keep the ethical integrity of a company intact, and to make sure that the business activities of the organisation are carried out within a regulatory framework.
Reporting to the Compliance Manager, in the Regulatory Affairs and Legal department, the Compliance Associate will be responsible for ensuring cGMP appropriateness of operations. You will give support in ensuring that all continuous improvement activities are established, monitored and maintained in compliance with all applicable regulations, SOPs and company policies.
In addition, you will assist in regulatory inspections, risks assessments, monitoring of commercial activities, self-assessment initiatives and any remediation activities. As a key member of the Compliance team, you will ensure that the Management team is aware of compliance requirements. You will help to build an integrated plan that delivers the needed results and promotes growth in capability (skills and culture) for sustaining a quality-cultured environment.
- Help with research and keep the department on the lookout for existing regulations;
- Maintains knowledge and ensures understanding of current industry best practices;
- Conduct gap assessments to assess risks in regards to HC, FDA, EU and TGA regulations;
- Develop Corporate Quality Policies and Gap Analysis Questionnaires;
- Conduct audits to ensure compliance on an organizational level and standardization across al sites, and maintain of the audit log and audit records;
- Support compliance projects to address management questions or identified needs;
- Supports continuous improvement projects (based on trends, internal audit observations, etc.) that can be leveraged across departments, functions, and product families;
- Support the development and implementation of risk management strategies to ensure compliance with current and upcoming changes to regulations;
- Ensure standard operating procedures (SOPs) are compliant with applicable regulations through change request approval;
- Create and maintain Global Compliance Dashboards for Key Performance Indicators (KPIs);
- Participates in critical/major investigations as needed to address problems and assist in resolution; internal/external audits; site inspection readiness activities; quality agreements, etc. as needed;
- Act as Compliance representative to support new product introduction and product marketing initiatives;
- In collaboration with R&D, review and approve project plans and protocols/reports.
- Performs any other tasks assigned by Management.
TRAVEL: Up to two (2) weeks per year to attend conferences, audits and visits other MEDISCA facilities
- Demonstrates judgment and integrity, technical competence and knowledge critical for role
- Situational Awareness, able to pivot from the theoretical to the practical settings
- Investigative, leads improvement areas, develops procedures and processes
- Facilitate cross-functional collaboration and support to assigned projects;
- Good computer skills with MS Office and Adobe Acrobat
- Strong verbal and written communication skills (English and French)
- University degree in a science-related discipline
- Six (6) years experience in Quality or Regulatory in Biopharmaceutical or Pharmaceutical Industry
- Strong knowledge of GXP regulations (Canadian, US, Europe and Australia), knowledge of medical device regulations also preferred
- Experience in GMP inspections (Asset: Auditor Certification)
- Advanced knowledge of quality management systems and risk management tools
Be a part of our winning team and take advantage of the opportunity to excel in an exciting career that helps make a difference in the lives of millions of people through MEDISCA and the pharmacy compounding industry.
We thank all applicants for their interest in our company; however, we will only contact candidates who have been called for an interview.