Main functions:
pbuJob Description/u/b/pp/pdivdivpbspanSummary:/spanspan /span/bspan /span/p/divdivpspanspanResponsible for independently reviewing various technical reports and raw data generated in /spanspanLab Operations/spanspan. /span/spanspan /span/p/divdivpspan /span/p/divdivpbspanEssential Functions:/spanspan /span/bspan /span/p/divdivullipspanspanReview with minimum supervision all regular technical documents (e.g., batch testing, stability testing and method validation) and raw data generated in the /spanspanLab/spanspanoratories/spanspan with high quality and deliver within agreed schedule. /span/spanspan /span/p/lilipspanspanEnsure the test methods, protocols and Standard Operating Procedures (SOPs) have been followed by the /spanspanscientists//spanspanchemists/spanspan./span/spanspan /span/p/lilipspanspanVerif/spanspany/spanspan the integrity and traceability of all data generated and reported. /span/spanspan /span/p/lilipspanspanFollow up with /spanspanscientists//spanspanchemists/spanspan/technicians/spanspan to ensure that all necessary corrections are corrected in accordance with Good Manufacturing Practices' standard. /span/spanspan /span/p/lilipspanspanNotif/spanspany/spanspan department supervisor/manager regarding omissions, incomplete testing results or other irregularities. /span/spanspan /span/p/lilipspanspanMay be /spanspanrequired/spanspan to travel to different sites depending on business requirements (as /spanspanrequired/spanspan)/span/spanspan /span/p/lilipspanspanMaintain a safe working environment and report potential hazards./span/spanspan /span/p/lilipspanspanP/spanspanerform alternating or rotating shift work (as required)/span/span/p/li/ul/divdivpbspanREQUIRED QUALIFICATIONS/span/bspan /span/pp/ppbspanMust Have:/span/b/pp/ppspan- Previous Lab experience /span/ppspan- Knowledge of Empower software/span/p/div/divdivpspan /span/p/divdivpbspanEducation:/span/bspan /span/p/divdivpspanspanB/spanspanachelor of Science /spanspanin Chemistry or related science./span/spanspan /span/p/divdivpspan /span/p/divdivpbspanExperience: /span/bspan /span/p/divdivpspanspanMinimum 1/spanspan year of previous pharmaceutical analytical development experience. /span/spanspan /span/p/divdivpspanspanPrevious document/spanspan reviewer experience preferred. /span/spanspan /span/p/divdivpspanspanFamiliar with current ALOCA principles./span/spanspan /span/p/divdivpspan /span/p/divdivpbspanEquivalency/span/bispan:/span/ispan /span/p/divdivpspanspanEquivalent combinations of education, training, and relevant work experience may be considered. /span/spanspan /span/p/divdivpspan /span/p/divdivpbspanKnowledge, Skills and Abilities:/span/bspan /span/p/divdivpspanspanBasic/spanspan understanding the common analytical technologies (e.g., High Performance Liquid Chromatography (HPLC), Gas Chromatography, Ultraviolet (UV)/spanspan spectrosco/spanspanp/spanspany, titration/spanspan, and raw material testing/spanspan. /spanspanGood/spanspan written and oral communication skills. /spanspanUnderstanding of /spanspanGood Manufacturing Practices, International Conference of Harmonization (ICH) and United States Food Drug Administration (FDA) requirements. /spanspanShould/spanspan have GMP chromatography experience (Specifically EMPOWER is an asset). Direct pharmaceutical experience in a GMP environment./spanspan Strong organizational skills and detail oriented. Ability to meet deadlines and prioritize/spanspan./spanspan Demonstrated computer proficiency with Microsoft Office programs./spanspan /spanspanProficiency with the English Language./span/spanspan /span/p/divdivpspan /span/p/divdivpbspanStandards and Expectations: /span/bspanspan /span/spanspan /span/p/divdivpspanspanFollow 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 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 /spanspanstrive 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. /spanspan /span/spanspan /span/p/divdivpspan /span/p/divdivpbspanPhysical Requirements:/spanspan /span/bspan /span/p/divdivpspanspanPosition requires ordinary ambulatory skills and physical coordination sufficient to move about /spanspanlab/lab office/spanspan 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 pound/spanspans/spanspan; 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. /spanspanUse of Personal Protective equipment may be required and may include any of the following: /spanspanSafety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally./span/spanspan /span/p/divdivpspan /span/p/divdivpbspanDisclaimer: /span/bspan /span/p/divdivpspanspanThis 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./span/spanspan /span/p/divdivpspan /span/p/divdivpspanspanNothing 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./span/spanspan /span/p/div
