Quality Assurance Associate

7 days ago

North York, Canada DALTON PHARMA SERVICES Full time

We have an opportunity for a 16-month contract Quality Assurance Associate position that lives in the Toronto area with high energy level and initiative, you should have a B.Sc. or higher degree in Chemistry, Biochemistry or Microbiology or 5+ years Quality Assurance and QA Compliance experience in the pharmaceutical industry, excellent knowledge of the Canadian GMPs, US cGMP’s, Health Canada, FDA, and ICH guidelines and strong verbal and written communication skills. Experience in interacting with regulatory agencies in an audit setting and correspondence would be an asset. Experience in a QC laboratory setting and instrumentation.

**Responsibilities**:

- Perform or approve deviation, especially QC LIR/LE 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.
- Review CRs related to CAPAs and ensure they are implemented and closed in a timely manner.
- Review test methods and associated protocols, as applicable.
- Ensure that Dalton employees follow GDP on all documents and maintain compliance.
- As part of the self-inspection team, perform internal audits to ensure SOPs and regulatory requirements are met.
- Work with Supervisor to ensure GMP Material Vendors, GMP Contractors and GMP Service Providers are audited as per schedule.
- Participate, prepare documents, and provide support during regulatory/customer audits and preparing responses to audit observations.
- Assist with external audit readiness (Regulatory inspection and Client audits), participate in audit/inspections and prepare audit responses.
- Write, review and/or approve Standard Operating Procedures.
- Review Logbooks for compliance and completion.
- Support investigations of product and vendor complaints and product recalls.
- Assist with the writing of annual product reviews and in the creation of trend reports of quality systems.
- Prepare and execute mock recall under the guidance of the supervisor.
- Administrative functions - attend meetings, timesheets, copying of documents for customers, creation of logbooks, filing of GMP documents and archiving of GMP records.

**Job Type**: Contract
Contract length: 16 months

Flexible Language Requirement:

- French not required

Schedule:

- Monday to Friday

Work Location: In person

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