QA Associate

2 weeks ago

Toronto, Canada Dalton Pharma Services Full time

We are seeking a skilled Quality Assurance Associate with high energy level and initiative, to ensure that products manufactured at Dalton Pharma Services for human use are safe and meet the pre-determined quality specifications, and that Dalton Pharma Services follows the applicable regulatory guidelines for GMP (e.g. Health Canada, FDA and ICH) and maintains a state of compliance.

**Responsibilities**:

- Assist in providing GMP operational guidance to All Dalton employees.
- To ensure that documents in use have been properly approved, meet the GMP requirements and are current.
- To review and approve new documents such as master batch records, test specifications and SOPs.
- To review and approve executed documents, such as batch records, work sheets and material release documents.
- Perform or review deviation investigations, operational investigations in particular, and ensure appropriate CAPA are put in place.
- Review and approve Master Batch Records to ensure they meet Dalton SOPs, Customer expectations and regulatory requirements.
- Review and sign off executed batch record packages (checklist). Including, but not limited to, Sterile Products.
- Review and approve Media Fill protocols and reports
- Perform or support deviation investigations, write/review associated impact assessment and determine/confirm root cause analysis.
- Help to develop and review/approve SMART CAPAs. Determine appropriate effectiveness checks and ensure CAPA closure.
- Assist with the implementation of CAPAs by reviewing CRs and ensuring timely implementation.
- Write, review and/or approve Standard Operating Procedures.
- Perform AQL inspections of finished product filled vials
- Perform aseptic coaching (observe operations during filling) and spot checks.
- Participate and provide QA support in regulatory inspections.
- Review IQ/OQ/PQ protocols and reports.
- Review risk assessments.
- Review EM trend data reports.
- Provide QA support in project calls when required.
- Understand project and client requirements and match them with regulatory requirements.
- Assist during customer audits, perform self-inspections and help to provide responses to external audits.
- Administrative functions - attend meetings, timesheets, copying of documents for customers, creation of logbooks, filing of GMP documents and archiving of GMP records.
- Perform other duties as assigned by QA management.

Qualifications:

- B.Sc. in a science discipline
- Microbiology Courses at the university level
- Working knowledge of GMP regulations (Health Canada and FDA).
- More than 5 years' experience in the pharmaceutical field.
- Experience in the area of QA compliance.
- Exposure to aseptic/sterile manufacturing.
- Strong verbal, communication and interpersonal skills
- Good command of Microsoft Office and general computer skills.

**Job Types**: Full-time, Permanent

Pay: $55,000.00-$70,000.00 per year

Additional pay:

- Overtime pay

**Benefits**:

- Casual dress
- Company events
- Dental care
- Extended health care
- Life insurance
- On-site parking
- Paid time off
- RRSP match
- Tuition reimbursement

Schedule:

- 8 hour shift

Work Location: In person

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