Quality Assurance Documentation Auditor Level 2
Quality Assurance Documentation Auditor Level 2
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Salary Not Disclosed
1 Vacancy
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 OOS and deviations approved have no regulatory complications. Reviews/revises SOPs for the purpose of corrective actions from internal and external audits. Generates responses to corrective actions from external audits. Trains analysts in GMP documentation. Performs Change control function as needed and other QA duties.
- Assures that reviewed QC records and C of A are compliant to methods specifications and companys 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 nonvalidated/transferred methods as per SGS. SOPs. Issues R of A instead.
- Assures review of data in LIMS and Intact 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 Document.
- Reviewer for correction according to Data Review SOP; Ensures that all valid deficiencies are corrected.
- If too many deficiencies or repeatable observations are found informs QA Supervisor.
- Assures OOS Investigations and Deviations are reviewed / concluded / approved in compliance with SGS OOS Investigation and Deviation SOPs and regulations.
- Has documented approved Qualified Trainer record for the aspects he/she trains others. Trains new QA Document Auditor for some test methods review GDP process and SGS SOPs
- Performs QA administrative duties: filing and other.
- Informs the Department Head if the due date is overdue on the worksheet or assigned work cannot be satisfactorily completed on scheduled time.
- Ensures that documentation review is complete in every respect and reviews that all results are
- entered into the electronic laboratory information system LIMS; Generates Certificate of Analysis and / or Stability Protocols / Reports and approves before submission to the client and /or faxes to client for approval and / or provides to the Department Head for submission to the client.
- 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.
- Issues test solution standard solution mobile phase and volumetric/colorimetric labels to laboratory as required; reviews and approves their preparations and labeling.
- Performs Change control function.
- Involved in problem root cause analysis and proposal / implementation to effective corrective actions.
- Requests training if work assigned requires knowledge of SOP with no record of training or reads and asks questions about SOPs in training.
- Trains departmental staff on documentation and regulatory issues.
Qualifications :
- Education: Bachelor of Science degree in Chemistry Biochemistry Biology Microbiology or related biological science or equivalent in job experience
- Experience: over 10 years experience working in a pharmaceutical regulated Laboratory environment or pharmaceutical company.
Additional Information :
SGS is an Equal Opportunity Employer and as such we recruit hire train and promote persons in all job classifications without regard to race color religion sex national origin disability age marital status sexual orientation gender identity or expression and Indigenous status or any other characteristics protected by law.
To perform this job successfully an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge skills and/or abilities required.
This job description should not be construed as an exhaustive statement of duties responsibilities or requirements but a general description of the job. Nothing contained herein restricts the companys rights to assign or reassign duties and responsibilities to this job at any time.
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.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
