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Irfa******
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Canada
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Last Update: 13.06.2019 at 10:42
Job Type
Full Time
Start
Jun , 2019
Duration
6 Month
Place
Brantford, CA
Country
Canada
Category
Description
Job Summary Keeps abreast of new regulations/guidelines, emerging regulatory agency and industry trends and keeps Management aware of developments. Uses sound, technical judgment in making decisions and recommendations and adheres to Company policies, CGMPs and applicable Standard Operating Procedures when performing job responsibilities and assigned tasks. Effectively manages workload and prioritizes work in line with the overall department and Company objectives and requirements. Ensures validation activities are performed and completed in a timely manner. Adheres to schedules, provides timely reports/assessments and ensures appropriate corrective and preventative actions are identified and implemented in a reasonable timeframe. Ensures information contained in protocols and reports, as well as that provided to support changes and/or qualification/revalidation is clear, concise, accurate, meaningful, scientifically sound, and well documented. Maintains complete and accurate documentation/records/data (electronic or paper), filed in an organized and easily retrievable manner. Ensures electronic information systems/databases are both effective and efficient and meet the needs of the department and Company. Works on continual quality system improvements and efficiencies, developing new or modifications to existing systems, as required. Provides support, guidance and functional direction in the area of validation and compliance. Provides routine progress reports and keeps QA management informed of on-going activities. Works independently or as part of a team, and conducts oneself in a professional manner fostering a positive work environment Works as a member of a team to achieve all outcomes. Performs all work in support of our Corporate Values of Passion, Perseverance, Collaboration and Courage; Demonstrates strong and visible support of our values. Performs all work in accordance with all established regulatory and compliance and safety requirements. Job Responsibilities Acts as primary QA representative in the company-wide Computerized System Validation Program; as an active standing member of the CSV team, is responsible to fulfil all responsibilities as laid out in company governing policies and procedures. Reviews, recommends and implements changes to validation program, quality systems, and approved procedures as required, ensuring information, processes, directives, etc. are accurate, practical, and compliant to Regulatory and Industry standards. Spearheads and monitors Computer System Validation projects and provides the necessary guidance to other site personnel to ensure satisfactory and timely completion of all validation activities. Liaises between Quality Assurance and Information Systems, and other departments within Apotex Pharmachem Inc. in relation to the creation, review, and approval of validation deliverables, operating procedures, and quality systems. Co-ordinates, schedules and performs the review and approval of protocols and reports, i.e., DQ, IQ, OQ and PQ, relating to the Qualification of Computerized Systems and other validation/qualification documents as required. Reviews the user, functional, GXP requirements, and ensures successful execution of validation program requirements.