Work Schedule
Standard Office Hours (40/wk)
Environmental Conditions
Office
Job Description
How will you make an impact?
Support and ensure adherence to established Standard Operating Procedures (SOPs) for conducting and generating the Annual Product Review (APR) report. Function as a liaison between several internal departments with the intent to gather relevant data. Support the compilation of product data for the review period with the objective of verifying the consistency of existing process, the appropriateness of current specifications, highlighting any trends and identifying both product and process improvements for the drug product. Provide support for various activities within the Quality Systems department. Provide training and support to Annual Product Review coordinators and Annual Product Review Associates. Assess changes to Regulatory, corporate and industry standard to determine site impact.
What will you do?
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Compile and review drug product data including batches manufactured, quantity, test results, manufacturing and laboratory investigation, product quality related complaints, stability data, change controls, specification changes, validation activities, etc.
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Perform administrative tasks of data entry, generates trending reports and statistical data analysis for Annual Product Reports.
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Work with clients to address issues related to Annual Product Reviews to complete reports in a timely manner.
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Provide administrative support for various internal, external and regulatory requests.
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Provide support for other quality systems within the Quality Systems Department, as needed. (e.g. GVault System, Change control approvals, MBR approvals, Data Integrity, eDMS, GTW and LMS support)
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Provide training and technical expertise to other APR Coordinators and APR Associates.
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Assess changes to Regulatory, corporate and industry standard to determine site impact.
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Participate in improvement events on behalf of the annual product review team (as required)
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Provide ongoing suggestions for improvements for quality and efficiencies in performance and completion of change controls.
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Provide support for other quality systems within the Quality Systems Department, as needed. (eg. eDMS, GMP Training, change control approval, master batch record approval).
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Maintain a safe working environment and report potential hazards.
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Perform alternating or rotating shift work (as required)
How will you get here?
Education:
College/Technical School Diploma in relevant field
Bachelor of Science (B.Sc.) an asset.
Experience:
Minimum 4 year of previous related experience in the pharmaceutical/food/cosmetic industry, preferably in a QA function.
Equivalency:
Equivalent combinations of education, training, and relevant work experience may be considered.
Knowledge, Skills, and Abilities:
Familiar with SOPs and Good Manufacturing Practices (GMPs). Detail oriented with a high degree of accuracy and thoroughness. Demonstrated computer proficiency with Microsoft Office programs. Intermediate Excel proficiency - data entry and plotting data for statistical graphs. Excellent organizational skills and ability to prioritize in a face-pace environment. Works well and efficiently with limited supervision. Strong written and oral communication skills. 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 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:
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 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.
Benefits
We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, company savings plan, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.
