- 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.
Apollo Health And Beauty Care
As a leader in its industry, Apollo has been recognized as one of Canada’s 50 Best Managed Companies 12 years in a row, proudly employing over 600 people in the community. For 22 years, Apollo empowered hundreds of retailers of all sizes, thousands of suppliers and millions of consumers worldwide by providing deluxe skin care, hair care and countless luxurious bath and body products. We are a true Canadian success story with formidable market penetration and distribution in North Americas, Europe, and Asia.
Apollo Health and Beauty Care recognizes hard-work and rewards merits. We encourage team work and provide top-notch training for all our employees. It has been Apollo’s goal to differentiate itself by providing an innovative and dynamic company culture and we are currently hiring a strong talent to support our ever-growing business.
Company Website: www.apollocorp.com
(if you already have a resume on Indeed)