Document Reviewer I

Location/Division Specific InformationWork Location: Whitby, Canada (on-site)

Group: Pharma Services Group

Division: Drug Product Division

Summary

Responsible for reviewing all data, lab notebooks, and completed Certificates of Analysis (C of A) and Stability reports generated in the Laboratory. Verifies and confirms the integrity and traceability of all data generated and reported.

Essential Functions

• Reviews with minimum supervision all regular technical documents (e.g., batch testing, stability testing method validation, raw materials and packaging components) and raw data generated in the Laboratory with high quality and deliver within standard time.
• Ensures the test methods, protocols and Standard Operating Procedures (SOPs) have been followed by the scientists/chemists.
• Verifies the integrity and traceability of all data generated and reported.
• Follows up with scientists/chemists to ensure that all necessary corrections are corrected in accordance with Good Manufacturing Practices’ standard.
• Notifies department supervisor/manager regarding omissions, incomplete testing results or other irregularities.
• Adhere to assigned schedules and standard times
• Performs alternating or rotating shift work (as required).

REQUIRED QUALIFICATIONS

Education

Bachelor of Science in Chemistry or related science.

Experience

Minimum 1 year of previous pharmaceutical analytical development experience.                         

Equivalency

Equivalent combinations of education, training, and relevant work experience may be considered.

Knowledge, Skills and Abilities

Basic understanding the common analytical technologies (e.g., High Performance Liquid Chromatography (HPLC), Gas Chromatography, Ultraviolet (UV) spectroscopy, and titration. Knowledge in Empower, LIMS and Nugensis and Trackwise software.  Good written and oral communication skills.  Understanding 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 systems SOP's 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.