QA Associate

3 weeks ago

Toronto, Canada Brevitas Full time

Resolute Workforce Solutions (Staff augmentation subsidiary of BrevitasConsulting Inc.) is dedicated to helping organizations achieve tangible resultsand lasting improvements via successful project delivery, continuous processimprovement, and effective management of change. Our expertise is inCommissioning & Qualification, Validation, Quality Systems, RegulatoryAffairs, Engineering, and Project Management.

We are looking for a highly motivated and energetic professional to joinour team as a  QA Associate – Batch Release  inthe  GTA, ON .

This is an on-site position.

Responsibilities:

Review batch record supporting documentation ( logbooks, mediarecords, tank processing, temperature/humidity charts) to release products andAPI. Collect, review, and approve all required documentation necessary forproduct release, including batch documentation review. Support investigations and corrections for incomplete/unexplained issuesfound during batch record review process. Load approved batch record templates onto the Document Generator system. Track and publish completion of corrective actions resulting from batchrecord issues. Assist quality administrative and customer service functions. Perform periodic ( Annual) compliance requirements such as executedbatch record review, stability review, APQR. Manage dates of delivery milestones and provide status updates tostakeholders. Participate and support Regulatory Inspections (Health Canada), as wellas internal and corporate audits.

Qualifications:

Bachelor ofScience degree, with specialization in Biology, Chemistry, or related sciences. Minimum of3+ years of related experience within the pharmaceutical industry. Experiencewith Regulatory Inspections (Health Canada), as well as internal and corporateaudits. Good tohave: Understanding of Health Canada complaint regulations for drug products.

ToApply:

Click the “I’m interested” button below, or E-mail your resume in MSWord or pdf format to with the following details in the e-mail's Subject Line:  QA Associate – Batch Release : FIRST NAME, LAST NAME.

Wethank all applicants in advance; however, we will only contact the candidateswhose qualifications match closely to the job requirements.

We welcome and encourage applications from people with disabilities.Accommodations are available on request for candidates taking part in allaspects of the selection process.

Review ourfor more information.

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