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

 

Business Title: Document Reviewer II - QA 

Summary:  

Responsible for 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. 

 

Essential Functions:   

Review all regular technical documents (e.g., batch testing, stability testing, method development and validation, raw materials and packaging components) and raw data generated in the Laboratory with high quality and deliver within standard time.  

Review and approve TrackWise OOS/DRs generated by laboratory 

Release Raw Material and Packaging Components in SAP 

Release of Product Certificate of Analysis using applicable LIMS software  

Ensure the test methods, protocols and Standard Operating Procedures (SOPs) have been followed by the scientists/chemists.  

Verify the integrity and traceability of all data generated and reported.  

Follow up with scientist/chemists to ensure that all necessary corrections are corrected in accordance with Good Manufacturing Practices’ standards.  

Notify department supervisor/manager regarding omissions, incomplete testing results or other irregularities.  

Write/Update SOPs and initiate change control when necessary. 

Adhere to assigned schedules and standard times. 

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 3 years 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 Nugensis and Trackwise software.    Excellent written and oral communication skills.  Good 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. 

 

Disclaimer:   

This job description is intended to present the general content and requirements for the performance of this job.  The description is not to be construed as a comprehensive statement of work, responsibilities, or requirements.  Managers and supervisors may assign other duties as needed. 

 

Nothing contained herein should be construed to create an employment contract.  Occasionally, required skills/experiences for jobs are expressed in brief terms.  Any language contained herein is intended to fully align with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.