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Biotech Document Reviewer

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Quality
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047649 Requisition #
Type of employment: Regular
Business Line: Life Science Services

Reporting to:  Biotech Scientific Leader

Location: Mississauga, ON
 
About SGS:

Make an impact with SGS! With more than 97,000 employees and 2,600 offices and laboratories across 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 the SGS Group as one of the world’s top multinationals and one of the world’s most innovative companies. The Dow Jones Sustainability Index has also recognized the SGS Group for its sustainability processes. In Canada, SGS employs over 2,000 team members across 70 locations.

 
A day in the life of a Biotech Document Reviewer at SGS Canada:
  • Assures that reviewed QC records are compliant to methods, specifications and company’s applicable Standard Operating Procedures.
  • The review is done according to QAM-210 Data Review SOP
  • Assures records of Validation/Method Transfer/Verification and reports are as per protocol and method provided by clients or written by SGS
  • Assures that OOS and deviation are closed before forwarding the records to QA for release of C of A.
  • Ensures test results are reported appropriately on either a C of A or a R of A depending on the validation/transfer status of the method.
  • Assures review of data in a timely manner and approval of records prior due date.
  • Assures method development records are reviewed as per SGS SOPs;
  • Issues an audit form noting deficiencies to method and procedures, returns the form to analyst for correction according to Data Review SOP; Ensures that all valid deficiencies are corrected; escalates all concerns to management.
  • Informs analyst or his/her supervisor  to initiate out -of-specification and/or issue OOS form in case of OOS, which was not noted by analyst;
  • Has and maintains documented, approved Qualified Trainer record for the aspects he/she trains others. Trains new Document reviewer for some test methods, review GDP process and SGS SOPs Requests deviation to be reported or issues a deviation report in case where method or SOP was not followed as written.
  • Revises forms for execution of methods and procedures; issues CCR for method change and new worksheet generation.
  • Attends training sessions and ensures that training binder is current. Has a training record for every SOP version executed, if applicable; If absent during training sessions, ensures training is performed and documented;


Ideal Candidate:
 
  • Bachelor of Science degree (or equivalent combination of education and experience such as College with 10 years of pharmaceutical QC testing/records review experience) in Chemistry, Biochemistry, Biology, Microbiology or related biological science or equivalent in job experience
  • Over 2 years experience working in a pharmaceutical regulated Laboratory environment or Pharmaceutical company.  
  • Ability to critically evaluate and review almost all test records generated by SGS
  • Excellent language, writing and communication skills required.
  • Thorough knowledge of scientific principles pertaining to analytical records reviewed
  • Ability to interpret, analyze data and draw logical conclusions required.
  • Proven time management skills and a strong attention to detail
  • Responsible to deadlines
  • Proficient in using various types of computer software (Word, Excel. PowerPoint & Outlook, LIMS and equipment software).
  • Extended hours or weekend work may be required from time to time.
  • Shift work may be required.
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.

 

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