Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office
Our Whitby Site specializes in commercial manufacturing for a full range of conventional dosage forms with specialized capabilities, and houses a fully integrated pharmaceutical development services (PDS) facility.
Discover Impactful work:
To conduct internal, external and client Good Manufacturing Practices (GMP) audits.
Day in the Life:
Performinternal Good Manufacturing Practices audits of all departments asrequiredand prepare writtenreportsto document the findings
Participate in thesite Fit and Finish Audit
Facilitate site preparations andexecuteauditsfor clients and regulatoryinspectionsincludingregulatory awareness programs for each agency.
Assistwith ongoing guidance and training of auditors(if applicable)
Assistwith regulatory requests.
Manage Audit Observations and AuditCAPAs
Provide administrative support for ongoing Compliance projects.
Maintain a safe working environment and report potential hazards.
Keys to Success:
Education:
Bachelor of Science (B.Sc.) in Chemistry, Biology, Pharmacy, orotherrelated field
Experience:
Minimum3yearsofGood Manufacturing Practices /Good LabPracticesauditing experience in pharma/medical devices.
Experience with SAP (an asset)
Equivalency
Equivalent combinations of education, training, and relevant work experience may be considered.
Knowledge,Skills,and Abilities
Exceptional Good Manufacturing Practices, GLP, and HPBI/FDA compliance knowledgeProficiencywith the use of quality investigation tools – FMEA, Fishbone, etcFamiliaritywithSFLMSFamiliarity with managing GMP regulatory requestsDetail-orientedand organized, with a high degree of accuracy and thoroughnessExcellent organizational skills and ability to prioritize in afast-pacedenvironment.Strong written and oral communication skillsWorks well and efficientlywith limited supervision.Demonstrated computerproficiencywith Microsoft Office programs.Proficiencywith the English Language.
Physical Requirements:
Light physical effort and fatigue. Walks,sitsor stands for limited periods. May require occasional equipment operation including keyboard equipment. Lifts light items for limited duration. Typicallylocatedin acomfortable indoor areaThere may be regular exposure to mild physical discomfort from factors such as dust, fumes orodours, temperature extremes, loud noise, strong drafts, or bright lights.Use of Personal Protective equipment may berequiredand may include any of the following: safety glasses, safety shoes, lab coat, gloves,hair net, beard cover,safety apron,andrespiratoronoccasionally
Excellent Benefits
Medical, Dental, & Vision benefits-effective Day 1
Paid Time Off & Designated Paid Holidays
Retirement Savings Plan
Tuition Reimbursement
OTHER
Relocation assistance is NOT provided.
Must be legally authorized to work in Canada now or in the future, without sponsorship.
Must be able to pass a comprehensive background check.
Compensation
The estimated annualized pay range for this position in Ontario is $69,400.00–$104,050.00.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
For more information, please visit www.thermofisher.com.
