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Irfa******
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Canada
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Last Update: 06.05.2019 at 05:41
Job Type
Full Time
Start
Jun , 2019
Duration
6 Month
Place
Mississauga,Canada
Country
Canada
Category
Healthcare
Description
SPECIFIC RESPONSIBILITIES: Promotes and maintains safe and healthy working conditions in his/her assigned work area; instructs and enforces compliance with established safe work practices and procedures; ensure assigned trainees receive appropriate training and information necessary to conduct their activities in a safe and healthy manner. Performs pre-assessment (prior to purchase) for analytical instrumentation and fills in the GMP risk assessment sheet. Performs calibration and preventative maintenance for analytical equipment as per calibration schedule. Assists in the preparation and execution of IQ/OQ and PQ protocols for analytical equipment. Creates, revises and trains lab personnel on Standard Operating Procedures for new or existing lab equipment. Provides hands-on training and support to the Analysts in the lab on analytical instrumentation use as required. Reviews and revises calibration procedures of existing equipment, if needed. Deploys and maintains analytical instruments and related software in accordance with GMPs, GAMPs, 21 CFR Part 11 and current regulatory expectations for data governance and data integrity. Ensures that lab equipment is calibrated in a timely manner and is available for use. Maintains calibration schedule; documents, organizes and maintains all calibration data. Writes or assists in writing deviations, Change Controls, Equipment Repair Reports and Out of Specification Calibration Reports pertaining to lab equipment as required and in compliance with GMP’s. Reviews and approves instrument qualification, verification, and calibration and repair documents in accordance to GMP requirements. Troubleshoots or participates in the troubleshooting of instrument problems and communicates with vendors/suppliers to resolve problems and arrange repairs. Investigates or participates in investigating Out of Specification calibration results and brings them to closure. Coordinates with external vendors and contractors and arranges for service, purchase of spare parts, new instruments and instrument qualification. Participates in and supports Lean initiative and Continuous Improvement projects in the QC Laboratory to enhance equipment readiness, right first time and reducing waste. Maintains Vendor Qualification list and follows up towards expiry and keep the list updated. Other duties as assigned. QUALIFICATIONS: Minimum Bachelor of Science Degree in in a Science related field. Minimum 3 years of experience in calibrating, qualifying, troubleshooting and maintaining laboratory equipment in a GMP environment. Familiarity with analytical testing requirements with good working knowledge of GMP’s., current regulatory (Health Canada, FDA, ICH) and pharmacopoeial requirements for validation and calibration of laboratory equipment. Sound knowledge and proficiency with the operation, troubleshooting and minor repair of complex and simple analytical instrumentation (FTIR, HPLC, GC, Dissolution equipment, pH Meter, Viscometer, Karl Fisher, AA, UV, etc.). Knowledge and understanding of applicable software used in the laboratory for data acquisition, in the science of measurement as well as in data integrity/data governance expectations. Flexible with the ability to adapt, respond quickly and manage change in a fast paced environment. Good verbal and written English communication skills and ability to write clear, concise reports and procedures/ instructions. Good working knowledge of Microsoft Office programs as well as laboratory software connected to different instrument (e.g. Empower, Agilent Mass Hunter, etc.) Demonstrated adherence to CPL’s core values of Integrity, Respect, Trust and Fairness. PHYSICAL DEMANDS AND WORKING CONDITIONS: Exposure to laboratory work conditions as well as to office environment. Lab presence requires use of protective equipment, such as safety glasses, lab coat and appropriate footwear, to reduce personal exposure and injury. Reaching and bending and some light lifting on a daily basis when preparing solutions. Flexibility in hours of work to address emergency issues outside of normal workday.