Documentation Reviewer I
Job Description
Summary:
Responsible for independently reviewing various technical reports and raw data generated in Lab Operations.
Essential Functions:
Review with minimum supervision all regular technical documents (e.g., batch testing, stability testing and method validation) and raw data generated in the Laboratories with high quality and deliver within agreed schedule.
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 scientists/chemists/technicians to ensure that all necessary corrections are corrected in accordance with Good Manufacturing Practices’ standard.
Notify department supervisor/manager regarding omissions, incomplete testing results or other irregularities.
May be required to travel to different sites depending on business requirements (as required)
Maintain a safe working environment and report potential hazards.
Perform alternating or rotating shift work (as required)
REQUIRED QUALIFICATIONS
Must Have:
- Previous Lab experience
- Knowledge of Empower software
Education:
Bachelor of Science in Chemistry or related science.
Experience:
Minimum 1 year of previous pharmaceutical analytical development experience.
Previous document reviewer experience preferred.
Familiar with current ALOCA principles.
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, titration, and raw material testing. Good written and oral communication skills. Understanding of Good Manufacturing Practices, International Conference of Harmonization (ICH) and United States Food & Drug Administration (FDA) requirements. Should have GMP chromatography experience (Specifically EMPOWER is an asset). Direct pharmaceutical experience in a GMP environment. 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:
Position requires ordinary ambulatory skills and physical coordination sufficient to move about lab/lab office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Use of Personal Protective equipment may be required and may include any of the following: Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator 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.