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Regulatory Compliance Specialist

3 months ago

Mississauga, Ontario, Canada Thermo Fisher Scientific Full time

Impact on the Organization:

The primary responsibility is to execute and oversee Client, internal, and external supplier Good Manufacturing Practices (GMP) evaluations.

Engage with Health Authorities and Clients during site evaluations and regulatory assessments.

Key Responsibilities:

  • Coordinate site readiness and auditing processes for Client evaluations and regulatory health authority assessments.
  • Conduct internal Good Manufacturing Practices evaluations across all departments as necessary and compile written reports to document findings.
  • Execute external Good Manufacturing Practices evaluations on packaging components, raw material suppliers, contract laboratories, etc., as required, and prepare written reports to document findings.
  • Carry out site Fit and Finish Evaluations.
  • Oversee Audit Observations and Audit Corrective and Preventive Actions (CAPA).
  • Promote collaboration and lead discussions to address issues with other functional areas as needed.
  • Maintain up-to-date knowledge of Health Canada, Food and Drug Administration (FDA), EMA, WHO, and other relevant regulations.
  • Ensure compliance with the implementation of procedures regarding external inputs in accordance with legislation (directives, regulations, ICH, EMA, FDA, Health Canada, GMP, and corporate policies).
  • Provide administrative assistance for ongoing GMP Compliance initiatives.

REQUIRED QUALIFICATIONS

Education:

Bachelor of Science in chemistry, biology, pharmacy, or a related field.

Experience:

A minimum of 3 years of experience in Quality/Compliance. Auditing experience is advantageous.

Familiarity with SAP is a plus.

Equivalency:

Equivalent combinations of education, training, and relevant work experience may be considered.

Knowledge, Skills, and Abilities:

In-depth knowledge of Good Manufacturing Practices, GLP, and HPBI/FDA compliance. Proficient in quality investigation tools such as FMEA and Fishbone diagrams. Familiarity with SFLMS and managing GMP regulatory requests. Proficiency in Trackwise is an asset. Detail-oriented and organized, with a strong emphasis on accuracy and thoroughness. Excellent organizational skills with the ability to prioritize in a fast-paced environment. Strong written and verbal communication skills. Capable of working efficiently with minimal supervision. Demonstrated proficiency in Microsoft Office applications. Proficient in the English language.

Standards and Expectations:

Adhere to all Environmental Health & Safety Policies and Procedures. Collaborate effectively with team members, demonstrating positive team principles and partnering to achieve project and departmental goals. Execute all responsibilities in strict compliance with quality systems SOPs and Good Manufacturing Practices (GMP). Maintain a clean and orderly workspace. Actively participate in and adhere to departmental systems to ensure a smooth and efficient workflow (visual management, scheduling systems, etc.). Maintain a client and patient-focused approach at all times. Understand Key Performance Indicators and strive to enhance team performance by identifying areas for system improvements and engaging in problem-solving. Exhibit positive thinking and adaptability, motivating the team to adjust to changing priorities and new methodologies. Proactively identify opportunities for improvement in procedural execution. Communicate potential risks to timelines in a timely manner. Consistently seek to enhance skills and knowledge in the relevant field.

Physical Requirements:

Light physical effort may be required. The role involves walking, sitting, or standing for limited periods. Occasional operation of equipment, including keyboard equipment, may be necessary. Lifting of light items for short durations may be required. Typically, the work environment is comfortable and indoors, though there may be regular exposure to mild physical discomfort from factors such as dust, fumes, or odors, temperature extremes, loud noise, strong drafts, or bright lights. Use of Personal Protective Equipment may be necessary, which may include safety glasses, safety shoes, lab coats, gloves, hair nets, beard covers, safety aprons, and respirators on occasion.