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QA Lead Investigator Pharmaceutical

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Quality
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046572 Requisition #
Lead Investigator

Type of employment: Permanent

Location: Markham, ON

Business Line: Life Science Services

Reporting to: QA Manager
 
About SGS:

Make an impact with SGS! With more than 95,000 employees and 2,400 offices and laboratories around the world, SGS is a silent force working hard behind the scenes to deliver quality and integrity to businesses across nine industries. As the world’s leader in providing inspection, verification, testing and certification services, Forbes ranked SGS as one of the world’s top multinationals and the Dow Jones has recognized SGS for its sustainability processes. In Canada, SGS employs over 2,000 team members across 70 locations.

 
A day in the life of  QA Investigator at SGS Canada:
 
  • Provides guidance to OOS results investigations on a daily basis where SOP and regulatory guidelines are followed;
  • Provides guidance to operations on how to write the OOS; reviews and approves OOS investigations;
  • Provides support in OOS investigations to sequence of events and root cause analysis or other technique. Approves OOS hypothesis testing, repeat test and final OOS Investigation according to internal SOP. Decides together with operations on corrective /preventative action plans for OOS due to SGS and assures Invalidation of testing results is compliant with regulations;
  • Participates or leads CAPA /Complaints process. Investigates CAPAs of QA. Participates in CAPA; investigations if requested by CAPA owner or QA supervisory. Reviews, approves CAPAs according to CAPA SOP.
  • Initiates deviations, investigates deviations or approves deviations according to internal SOP and regulations.
  • Initiates / leads improvements to improve Key Performance Indicators KPIs for correctness of C of A.  Plots the C of A incorrect %/sample /total samples per month for root cause analysis; (or as revised by Management) Uses Pareto chart / risk analysis for scheduling corrective action and improvement to number of correct C of A; Plots KPIs for company objectives

Ideal Candidate:
 
  • Minimum education BSc. In Biology, chemistry or related fields.
  • Experience: 5 years in QA leading root cause investigations.
  • Skilled in pharmaceutical testing individual who has experience / capability to perform thorough investigations into root cause analysis
  • Knowledge of OOS Investigation regulatory process
  • Knowledge and experience of using root cause analysis tools
  • Thorough knowledge of scientific principles pertaining to records under investigation.
  • Works well under pressure and tight deadlines.
  •  Ability to work fast and make timely decisions where required (e.g. hypothesis testing, repeat test approvals e.t.c.)
  • Proven time management skills. Managing multiple assignments.
  • Highly organized
  • Deliver results in a timely manner
  • Proven track of working well with others.
  • Excellent written and verbal communications
 
Additional Information:
 

SGS Canada is an equal opportunity employer and we are committed to achieving greater accessibility by providing accommodation for people with disabilities during our hiring process.  Accommodations are available on request for qualified candidates during each stage of the recruitment process.


Please note that candidates applying for Canadian job openings should be authorized to work in Canada.


Visit www.sgs.com