Careers

North York, Ontario

Lead Investigator

Lead Investigator – Complaints
Toronto
1 yr

SUMMARY OF PURPOSE/MAJOR RESPONSIBILITIES

Combining a strong understanding of biological manufacturing processes, cGMPs (Current Good Manufacturing Practices), root cause analysis and technical writing skills with the responsibility for managing complaint investigations, manufacturing investigations (MI) related to adverse events, developing and implementing remediation activities and supporting the associated improvements in manufacturing areas as an outcome of the investigations performed.

An ability to execute and manage robust complaint and manufacturing investigations is crucial given the significance of complaint investigations during regulatory inspections.

Position has a high degree of autonomy and is expected to make decisions and interpretations within defined requirements of the position.

The Lead Investigator is a detail oriented and results driven individual with a strong understanding of biologics manufacturing, cGMPs, root cause analysis and possesses exceptional technical writing skills.
The incumbent is responsible for leading product complaint investigations within Product Surveillance team.

DIMENSIONS/SCOPE

  • 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 position may require interactions with external customers as a QO representative.
  • The number of investigations performed annually can range between 200 and 300. 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.

Education/Certifications

  • Minimum Bachelor of Science degree, with specialization in Biology, Biochemistry, Microbiology, Immunology, Pharmacology, Chemistry.
  •  
  • Experience
  • At least 5 years of pharmaceutical experience with related Quality experience in Quality Operations.

 

Competencies

  • 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 Ofiice (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 is required.
  • Excellent technical report writing and demonstrated ability to work independently
  • Excellent organizational, interpersonal and teamwork abilities are required.
  • Problem solving skills and analytical thinkings are essential skills for the role.

Our Advisor for this position

Wandalin Jana

Talent Acquisition Manager

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