Quality Portfolio Specialist, Audits(Job Number: 26004055)

Primary Location:ON-Markham

Pharma

Employee Type:Full-Time

Pay Rate From:67,200

Pay Rate To:84,000

Description:

JOB SUMMARY
The Quality Portfolio Specialist, Audits will support the entire audit lifecycle for internal and external audits, leading to greater compliance across the division.

DUTIES AND RESPONSIBILITIES

- Maintains Quality Management System policies and procedures in line with GxP
- regulations, ISO standards and Provincial College of Pharmacy regulations.
- Be responsible for the following external audits and self-inspection readiness related activities:
- Maintains key audit/inspection readiness documents to ensure the most up to date version and correct documents are available in the repository.
- Provides support with the coordination of internal self-inspections and external audits including but not limited to audit scheduling, pre-audit training, logistics, audit runner, document follow-up, and CAPA plan & tracking.
- Provides guidance and educates teams on conducting root cause analysis, investigations and writing effective CAPAs.
- Participates in internal review of audits documents.
- Supports the completion of Pre-Audit Surveys, Due-Diligence Compliance Questionnaires, Vendor Qualification Questionnaires, RFP Questionnaires, Third Party Risk Assessment Questionnaires and ABAC Questionnaires received from Pharma partners.
- Supports in identifying compliance gaps and developing a plan to eliminate/mitigate compliance gaps.
- Assists in creating and revising Specialty Program Portfolio and Division wide
- standard policy documents and standard operating procedures.




- Utilizes technical and business writing skills to effectively communicate
- process changes across the Specialty Program Portfolio.
- Monitors Health Canada, ISO and Provincial College of Pharmacy/NAPRA regulatory and quality requirements and proactively adapt the internal processes to meet the changing requirements.
- Must be able to interact with all levels of internal stakeholders and build a good rapport with internal stakeholders.
- Performs other quality and compliance related division wide duties as assigned.

Qualifications:

QUALIFICATIONS
EDUCATION

- Professional Scientific degree and/or combination of Quality, Regulatory Certification.

EXPERIENCE

- Minimum three (3) years of previous experience working with Quality initiatives in a healthcare setting.
- Experience in handling the Regulatory Board of Health Inspections and Global Pharma Compliance Audits is required.
- Experience working in Pharmaceutical GMP Quality and/or Regulatory environment is desired.
- Well versed with GxP documents and GxP regulations.
- Quality audit certification is an asset.
- Effective business writing skills are required.
- Effective technical writing skills in writing policies, standard process documents, work instructions.
- Experience in CAPA planning and follow-ups.
- Knowledge of current Pharmaceutical Quality Systems and Compliance standards.
- Experience working with Quality Systems including but not limited to: Document
- Management Systems, Change Control System, and Deviation/CAPA Management Systems.
- Knowledge of GDP (Positive Documentation Practices), GMP (Good Manufacturing Practices), Health Canada GVP (Good Pharmacovigilance Practices), NAPRA regulations and ISO standards

📌 Quality Portfolio Specialist, Audits (Markham)
🏢 Bayshore HealthCare
📍 Markham