Thermo Fisher Scientific Hiring for Sr Compliance Auditor at Mississauga, ON Full Time

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 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, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues 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 and Patheon. For more information, please visit www.thermofisher.com.

How will you make an impact?

You will conduct and host client, internal and external supplier Good Manufacturing Practices (GMP) audits. You will interact with Health Authorities and Clients conducting site audits, regulatory inspections and regulatory submissions.

What will you do?

Essential Functions:
Facilitates site preparations and leads auditing executions for Client audits and regulatory health authority inspections.

Performs and leads internal Good Manufacturing Practices audits of all departments as required and prepares written report to document the findings.

Performs and supports external Good Manufacturing Practices audits on packaging component, raw material suppliers, contract laboratories, etc. as required and prepares written report to document the findings

Performs and leads site Fit and Finish Audits.

Manages Audit Observations and Audit CAPA’s.

Verifies and enforces implementation of procedures of external inputs in terms of legislation (directives, regulations, ICH, EMA, FDA, Health Canada, GMP) and corporate policies.

Manages, maintains and verifies compliance with the Client’s CMCs and registration dossiers for drug products with internal company documents.

Facilitates and fulfills regulatory related requests from Clients and Health Agencies to ensure product drug submissions and product launches are completed within the required timeline and to follow Good Manufacturing Practices/Standard Operating Procedures (SOPs).

Ensures familiarity with Health Canada, Food and Drug Administration (FDA), EMA, WHO and other regulations

Leads GMP Compliance projects as assigned by quality management

Manages monthly GMP Compliance metrics.

Fosters co-operation and leads discussions to resolve issues with other functional areas (as required)

Assists with ongoing guidance and training of junior auditors (as applicable)

How will you get here?

REQUIRED QUALIFICATIONS

Education:
Bachelor of Science (B.Sc.) in Chemistry, Biology, Pharmacy, or other related field

Experience:
Minimum 5 years Good Manufacturing Practices /Good Lab Practices auditing experience.

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 (GMP), GLP, and HPBI/FDA compliance knowledge.

Proficiency with the use of quality investigation tools – FMEA, Fishbone, etc. Familiarity with SFLMS.

Familiarity with managing GMP regulatory requests.

Proficiency in TrackWise an asset.

Detail oriented and organized, with a high degree of accuracy and thoroughness.

Excellent organizational skills and ability to prioritize in a fast-pace environment.

Strong written and oral communication skills.

Works well and efficiently with limited supervision.

Computer proficiency with Microsoft Office programs.

Proficiency with the English Language.

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.