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Document Reviewer- Chemistry

4 months ago

Mississauga, Canada SGS Full time

Company Description

Make an impact with SGS With more than 94,000 employees and 2,000 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.

**Job Description**:
Performs review and approval of data based on document review in a timely and effective manner according to 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 are compliant to methods, specifications and company’s applicable Standard Operating Procedures.
- The review is done according to QAM-210 Data Review SOP
- Identifies area for improvement of SGS SOPs, analytical methods and forms.
- Follows deadlines specified on a lab sheet or as scheduled by their supervisor.
- 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.

**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 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
- As per SOP PSL-311-06 all employees must maintain appropriate attitude, constant vigilance and attention to detail. Understanding of the lab quality control / quality assurance processes, GMP and GDP as it relates to pharmaceutical testing
- Comfortable with electronic systems (e.g., LIMS) 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
- Able / willing to learn new skills (review of new tests, instrumentation and procedures) as required and follow directions from management including priorities
- Technically competent
- Ability to learn quickly in a challenging environment.
- 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.
- Must be highly organized and able to work effectively and efficiently in a demanding environment with flexibility to changing priorities.
- Ability to work well with others, independently and fostering teamwork throughout the laboratory
- 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).
- Proven ability to manage and coordinate multiple projects in a fast-paced, highly professional environment.

Additional Information