Quality Assurance Specialist

2 weeks ago

Toronto, Ontario, Canada Apollo Health And Beauty Care Full time
Job Title: Quality Assurance Associate

Apollo Health & Beauty Care is seeking a highly motivated and detail-oriented Quality Assurance Associate to join our team. As a Quality Assurance Associate, you will play a critical role in ensuring the quality and compliance of our products.

Job Summary:

The Quality Assurance Associate will be responsible for participating in the completion of milestones associated with specific projects and supporting ongoing Annual Product Reviews, Management of Deviations, CAPAs, Change Management, SOP Management, and general quality management systems responsibilities in support of the manufacture, packaging and release of commercial products.

Key Responsibilities:
  • Completes APR reports in accordance with the schedule, gathering information available from batch records, investigations, product changes, complaints etc.
  • Collaborates and liaises with business to review and manage Change Control Requests. Ensures GDP and change management procedures are followed.
  • Assists with monitoring all internal QMS compliance through performing internal audits, including production, facilities, validation, and the laboratories.
  • In collaboration with Quality colleagues identifies areas for continuous improvement within the QMS.
  • Acts as Subject Matter Expert (SME) for Quality Risk Management.
  • Reviews deviation and investigation records, includes tracking, follow-up, and reporting/trending. Ensures GDP and deviation procedures are followed.
  • Reviews Corrective and Preventative Actions (CAPA); includes tracking, follow-up, and reporting/trending and evaluating CAPA for effectiveness.
  • Works with all departments to guide the timely completion of Deviations, CAPA, Corrective Work Orders, Change Controls, and Investigations.
  • Helps the Quality Supervisor with the review of batch records for product release.
  • Generates and maintains Quality Assurance and QMS standard operating procedures (SOPs).
  • Oversees controlled document and system changes and performs detailed impact analysis to ensure all necessary GMP and qualification action items have been added to the change controls, as well as executed.
  • Collaborates significantly with cross functional groups, including Quality Assurance, Manufacturing, Process Development, Facilities, and Regulatory Affairs on quality assurance matters.
  • Cross-train with other QA Associates.
  • Responsible for Logbook issuance, control, and review.
  • Files and maintains controlled documents.
Requirements:

To be successful in this role, you will need:

  • 5+ years of GMP-related experience in biopharmaceutical or pharmaceutical manufacturing facilities.
  • Bachelor's degree or diploma in Chemistry, Biology, Engineering or related field.
  • Thorough knowledge of cGMP/GDP international regulatory compliance in addition to Regulatory/Operations experience in a GMP environment.
  • Ability to prioritize daily activities in order to meet internal and external customer needs in a fast-paced environment.
  • Ability to work on Quality projects where analysis of data requires evaluation of identifiable factors.
Working Conditions:

This role will be based in an office environment within a manufacturing environment with regular or some exposure to dirt, dust, grease, oil, noise or temperature extremes. You will frequently face multiple demands or distractions and have limited exposure to poor ventilation.

Apollo Health & Beauty Care Ltd. is an equal opportunities employer and welcomes applications from diverse candidates. We are committed to providing accommodations for people with disabilities in all parts of the hiring process. If you require accommodations, please let us know in advance.

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