QA Associate

6 months ago

Toronto, Canada Apollo Health And Beauty Care Full time

Apollo Health & Beauty Care (Apollo) is a premium developer of private label and control label health & beauty care products and leverages unique expertise and experience in developing national brand-equivalent products designed to compete equivalently with the most popular national brands. The largest private label and control label personal care manufacturer in Canada, Apollo has formidable penetration and distribution in the North American marketplace and also services customers throughout Central and South Asia, Mexico, Europe and Asia. Building on our core values of Excellence and Commitment, Apollo has established itself as a market leader that attracts the industry's top talent. We are currently searching for an energetic, motivated _**_QA Associate (12 Months Contract)_**_ to join our Team_

**_Position Summary_**

**This is a 12 months contract position**

Major duties performed include but are not limited to development, execution, presentation, analysis, tracking and gap analysis of Annual Product Reviews and related systems, documentation enhancement (including batch records, SOPs, investigations) audit support (internal and external), CAPA tracking and analysis.

**_Duties & Responsibilities_**

**Preparation of Annual Product Reviews for drug products**:

- 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

**Documentation Review/Optimization**:

- 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

**Audit support**:

- 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.

**_Education & Experience_**
- 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.
- The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Duties outlined on this job description may not be all-inclusive, and can be modified at any time if requested by management. Apollo is committed

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