Quality Assurance Associate
4 weeks ago
Immediate need for a talented Quality Assurance Associate with experience in the Pharmaceutical Industry. This is a 12+ Months contract opportunity with long-term potential and is located in North York, ON. Please review the job description below.
Job ID: 20-29630
- Triage of the reported complaint with the assistance of Manager to determine the appropriate criticality and classification of the reported defect to assess potential risk to marketed product associated to the complaint(s).
- Manage investigations by identifying required expertise (Production, MTech, Technical Services, QC, QOVS, QOSA, etc.) and leveraging the assistance of other departments or other sites to develop an investigational strategy.
- Review Batch Production Records and perform Root Cause Analysis as part of the complaint investigations; root cause analysis is performed by conducting process walks (GEMBA), selecting appropriate analytical tools and collecting and analyzing data to determine the true root cause.
- Examine all returned product complaint samples and submit for testing.
- Ensure all product retention examinations are performed to assist with the investigation.
- Collaborate with the Global Pharmacovigilance department to determine potential adverse event assessments (as required).
- Participate in Focus Factory Support teams for planning and execution of investigations, as required.
- Manage and coordinate sample shipment for investigational testing to be performed both internally and through external contract testing laboratories respecting required timelines to receive the result to apply to the complaint investigation.
- Develop appropriate corrective and preventive actions in collaboration with QO, various production areas and other sites.
- Identify reoccurring complaint defects and escalate as required for further corrective/preventive actions.
- Provide information to support the writing, review and submission of Biological Product Deviation Reporting (BPDR) to regulatory agencies.
- Manage the complaint review process and assists in ensuring that the complaint investigations are closed according to targeted timelines.
- Technical Complaints logged, categorization, receipt of sample (if available) request for Adverse Assessment and conclusion from Pharmacovigilance for those defects required and investigation to be performed in a timely fashion.
- Manufacturing investigations (MI) logged, investigated in timely manner and completed response sent to Global Pharmacovigilance.
- The position generally operates both in an office/sample storage facility. The environment requires intense concentration and visual examination of documents.
- The incumbent will be expected to independently manage the investigations in collaboration with supporting departments to ensure timely closure of complaints.
- Manage the categorization, planning, verification and approval of each assigned Change Control in collaboration with the responsible department to ensure timely closure.
- Evaluate the compliance of each master document (Product Specification, Standard Operating Procedures, maintenance task lists, and SWIs) procedure against established regulation, policies, and guidelines to approve the master documents.
- Manage CAPA projects with collaboration with the responsible department to ensure timely closure within agreed upon timelines.
- Minimum Bachelor of Science degree, with specialization in Biology, Biochemistry, Microbiology, Immunology, Pharmacology, Chemistry.
- At least 5 years of pharmaceutical experience with related Quality experience in Quality Operations.
- Strong GMP background including working knowledge of GMP and interacting with regulatory agencies.
- Knowledge and experience with multiple softwares/databases e.g. SAP, Trackwise, MS Office (Word, Outlook, Excel, Visio, PowerPoint and Teams).
- Ability to think and act strategically in a fast-paced environment and make balanced decisions related to quality.
- Ability to effectively communicate verbally and in writing through multiple layers of the organization; strong presentation skills are required.
- Excellent technical report writing and demonstrated ability to work independently.
- Excellent organizational, interpersonal and teamwork abilities are required.
- Problem-solving skills and analytical thinking are essential skills for the role.
Our client is a leading Pharmaceutical Industry and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.
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