QA Associate
Apollo Health & Beauty Care
- Toronto, ON
- Permanent
- Full-time
- Development of APR forms templates, databases, and related infrastructure to capture APRs in a compliant consistent method using information available such as SYSPRO, batch records, and forms.
- Defining products that require APRs and arranging for relevant information such as stability data, OOS information
- Executing APRs in logical orders and tracking completion against targets
- Analyzing results from APR studies and determining if CAPA tasks required of if CAPA tasks effective
- Analyzing related formulations or linked CAPAs or casualties
- Recommending CAPAs to address systemic issues as required
- Summarizing results of APRs in a variety of formats and technicality level
- Execution of the APRs
- Tracking progress of APR completion against previously agreed schedules or specific regulatory events such as audits
- In consultation with QA Manager and QC Manager, defining and coordinating corrective actions related to APR reviews
- Summarizing APR results in a variety of formats and evaluating results against defined criteria for internal use and external review to regulatory agencies
- Ensure CAPA documents are centrally tracked and recorded in a database format
- Organize CAPA tasks for easy information retrieval, information sharing and status updating using electronic tools
- Track CAPA performance against targets and report discrepancies
- Provide remediation recommendations to management as required
- Liaise with internal and external clients to ensure CAPA tasks are closed as per expectations
- Prepare summary documents in a variety of formats for a varied level of technical complexity
- Seek to always improved documents, SOPs and forms based on learning from CAPAs.
- Review of documentation prior to customer issuance for defined products
- Identifying any documentation errors and the root cause(s) of these errors. Determining potential solutions to the root causes and presenting to operations and quality management.
- Preparing presentation and training material in support of documentation enhancement
- Working with operations to improve and optimize documentation used in batch records
- Providing support to regulatory and sales staff as required for batch documentation
- Track audit activities & CAPAs for internal and external audits using electronic tools
- Assist with audit scheduling and coordination
- Assist QA Manager during audits as required
- Administrative support during regulatory or customer audits
- Tracking and reporting progress against identified corrective actions related to audits (internal to Apollo and supplier audits)
- Working with suppliers to properly document and close agreed corrective actions.
- Any other related duties as required.
- 3+ years’ experience within a similar role
- Post-secondary education in a related field required
- Excellent written and verbal English communication skills required
- Detail-oriented, accurate, strong organizational and time management skills.
- Demonstrated proficiency with MS Office products.
- Ability to work with diverse teams across different parts of an organization
- Strong work ethic and results orientation.