Sr Document Reviewer - QA
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)Job Description
Summary:
Responsible for independently reviewing all data, lab notebooks, and completed Certificates of Analysis (C of A) and Stability reports generated in the Laboratory. Verify and confirm the integrity and traceability of all data generated and reported. Generating idea and recommendations for system improvement.
Essential Functions:
Review all regular technical documents (e.g., batch testing, stability testing method validation, raw materials and packaging components) and raw data generated in the QC and PDS - Lab with high quality and deliver within standard time. Ensure the accuracy of calculations, and that testing methods and standard operating procedures have been followed during the performance of the analytical analysis; and verify the integrity and traceability of all data generated and reported.
Release Raw Material and Packaging Components in SAP.
Release of Product Certificate of Analysis using applicable LIMS software.
Review and approve TrackWise OOS/DRs generated by QC and PDS lab.
Work in accordance with approved methods, Standard Operating Procedures (SOPs) and cGMP (Good Manufacturing Practices).
Adhere to assigned schedules and standard times.
Consult with the department group leader/supervisor regarding omissions, incomplete testing results or other irregularities.
Write/revise SOPs and initiate change controls.
Act as a backup in the absence of Supervisor.
Assist the Supervisor/Manager with monitoring performance of the review group (as required)
Maintain a safe working environment and report potential hazards.
Perform alternating or rotating shift work (as required)
REQUIRED QUALIFICATIONS
Education:
Bachelor of Science in Chemistry or related science.
Experience:
Minimum 4 years of previous pharmaceutical analytical development experience.
Equivalency:
Equivalent combinations of education, training, and relevant work experience may be considered.
Knowledge, Skills, and Abilities:
Understanding the common analytical technologies (e.g., High Performance Liquid Chromatography (HPLC), Gas Chromatography, Ultraviolet (UV) spectroscopy, and titration. Knowledge in Empower, LIMS Nugensis and Trackwise software. Excellent written and oral communication skills. Excellent working knowledge of Good Manufacturing Practices, International Conference of Harmonization (ICH) and United States Food & Drug Administration (FDA) requirements. Strong organizational skills and detail oriented. Ability to meet deadlines and prioritize. Demonstrated computer proficiency with Microsoft Office programs. Proficiency with the English Language.
Standards and Expectations:
Follow all Environmental Health & Safety Policies and Procedures. Work collaboratively with fellow team members, modelling positive team principles and partnering to meet project and departmental objectives. Carry out all duties within strict compliance to Patheon quality SOPs and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion. Actively engage in and adhere to departmental systems in order to maintain a smooth and efficient workflow (visual management, scheduling systems, etc.). Be client and patient conscious at all times. Understand Key Performance Indicators and strive to improve the performance of the team by identifying areas for system improvements and engage in problem solving. Models positive thinking and is open to change, motivating the team to adapt to shifts in priorities and new ways of working. Proactively identify areas for improvement in the execution of procedures. Communicate risks to timelines in a proactive manner. Consistently strives to improve skills and knowledge in related field.
Physical Requirements:
Light physical effort and fatigue. Walks, sits or stands for limited periods. May require occasional equipment operation including keyboard equipment. Lifts light items for limited duration. Typically located in a comfortable indoor area. There may be regular exposure to mild physical discomfort from factors such as dust, fumes or odours, temperature extremes, loud noise, strong drafts, or bright lights. Use of Personal Protective equipment may be required and may include any of the following: safety glasses, safety shoes, lab coat, gloves, hair net, beard cover, safety apron, respirator on occasionally.