Quality Assurance Specialist

3 weeks ago

Toronto, Ontario, Canada Apollo Health And Beauty Care Full time
Job Summary

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

Key Responsibilities
  • Quality Management: Participate in the completion of milestones associated with specific projects and support ongoing Annual Product Reviews, Management of Deviations, CAPAs, Change Management, SOP Management, and general quality management systems responsibilities.
  • Regulatory Compliance: Collaborate and liaise with business to review and manage Change Control Requests, ensuring GDP and change management procedures are followed.
  • Internal Audits: Assist with monitoring all internal QMS compliance through performing internal audits, including production, facilities, validation, and the laboratories.
  • Continuous Improvement: Identify areas for continuous improvement within the QMS, in collaboration with Quality colleagues.
  • Quality Risk Management: Act as Subject Matter Expert (SME) for Quality Risk Management.
  • Deviation and Investigation Management: Review deviation and investigation records, including tracking, follow-up, and reporting/trending, ensuring GDP and deviation procedures are followed.
  • CAPA Management: Review Corrective and Preventative Actions (CAPA); includes tracking, follow-up, and reporting/trending and evaluating CAPA for effectiveness.
  • Quality Assurance Support: Work with all departments to guide the timely completion of Deviations, CAPA, Corrective Work Orders, Change Controls, and Investigations.
  • Batch Record Review: Help the Quality Supervisor with the review of batch records for product release.
  • Quality Assurance Documentation: Generate and maintain Quality Assurance and QMS standard operating procedures (SOPs).
  • Document Control: Oversee controlled document and system changes and perform detailed impact analysis to ensure all necessary GMP and qualification action items have been added to the change controls, as well as executed.
  • Cross-Functional Collaboration: Collaborate significantly with cross-functional groups, including Quality Assurance, Manufacturing, Process Development, Facilities, and Regulatory Affairs on quality assurance matters.
  • Training and Development: Cross-train with other QA Associates.
  • Logbook Management: Responsible for Logbook issuance, control, and review.
  • Document Filing: Files and maintains controlled documents.
Requirements
  • Education and Experience: 5+ years of GMP-related experience in biopharmaceutical or pharmaceutical manufacturing facilities. Bachelor's degree or diploma in Chemistry, Biology, Engineering or related field.
  • Knowledge and Skills: Thorough knowledge of cGMP/GDP international regulatory compliance, 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.
  • Interpersonal Skills: Regular access to confidential or sensitive information, frequent and regular internal interactions and frequent external interactions.
  • Problem-Solving and Judgment: Position has significant amount of autonomy in terms of level of monitoring and decisions generally do not follow prescribed guidelines.
  • Mental and Physical Effort: Requires high levels of concentration and/or attentiveness, sustained duration and/or intensity of efforts, moderate energy required in terms of standing, walking, lifting, keyboarding, pushing, pulling, sitting, packing, assembling, bending, or twisting.
  • Material and Information Resources: High level of consequence and costs associated with errors as related to losses of time, money, or property, high responsibility for significant machinery, work aids, equipment, materials, properties, products, stock, inventory, or tools.
  • People, Policies, and Practices: Quality assurance responsibility for people, policies or practices in terms of assuring compliance in accordance with company policies.
  • Financial Resources: Regular responsibility for financial data, money or financial transactions, budget management financial records, expenditures, acquisition, financial analysis, or risk management.
  • Environment and Hazards: Works in an office environment within a manufacturing environment with regular or some exposure to dirt, dust, grease, oil, noise or temperature extremes, frequent faces multiple demands or distractions, has limited exposure to poor ventilation.

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