Documentation Reviewer - Level 1 - Microbiology (PR)

  • Full-time

Company Description

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.

Job Description

  • Performs release of data and Certificate of Analysis (C of A) or Report of Analysis (R of A) based on document review in a timely and effective manner according to clients' methods, instructions, procedures, good laboratory documentation practices (GDP), good manufacturing practices (GMP) and standard operating procedures (SOPs) of SGS Life Science Services Analytical Laboratories and Departments.
  • Assures that reviewed QC records and C of A are compliant to methods, specifications and and company’s applicable Standard Operating Procedures; Prevents release of noncompliant C of A to client.
  • Assures records of Validation/Method Transfer/Verification and reports are as per protocol and method provided by clients or written by SGS
  • Prevents C of A issuance to be delivered to client for non-validated/transferred methods as per SGS SOPs. Issues R of A instead.
  • Assures review of data in a timely manner and release prior due date if records available for review;
  • Assures method development records are reviewed as per SGS SOP;
  • 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; If too many deficiencies or repeatable observations are found, informs QC Manager;
  • Assures OOS Investigations and Deviations are reviewed / concluded / approved in compliance with SGS OOS Investigation and Deviation SOPs and regulations;
  • Formulates responses to internal and external audit findings and corrective actions;
  • Files the final package of MV-MT-VER data in the QA room as per SGS SOPs;
  • Updates and follows up logs (e-log and hard copy) for MV-MT-VER projects;
  • Issues controlled copy of Validation/Transfer/Development/Verification protocol (backup);

Qualifications

  • Education: 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
  • Experience: over 5 years experience working in a pharmaceutical regulated Laboratory environment or Pharmaceutical company. 
  • Quality Assurance Professional understanding of the lab quality control / quality assurance processes, GMP and GDP as it relates to pharmaceutical testing
  • Comfortable with LIMS System and other lab equipment to be able to perform audit trail of testing records
  • Well organized, autonomous and able to deliver good quality work efficiently
  • Ability to learn quickly in a challenging environment.
  • Works well under pressure.
  • Extended hours or weekend work may be required from time to time.
  • Shift work may be required
  • Appropriate attitude, constant vigilance, attention to detail and following Training SOP for training and training records.

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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