Regulatory Compliance Specialist Jobs

BioNiagara a Contract Development and Manufacturing Organization (CDMO) based in St.Catharines, Ontario is searching for professional and talented individuals who are enthusiastic, goal oriented and focused on their future career. We look forward to hearing from you soon.
1. Education and Experience:
Bachelor's degree in a relevant scientific field, such as chemistry, pharmacy, biology, or a related discipline.
Previous experience working in a GMP- regulated industry, such as pharmaceuticals, biotechnology, medical devices, or food manufacturing, with a focus on quality assurance.
Familiarity with GMP regulations and guidelines, such as FDA regulations, EU GMP, or ICH guidelines.
Experience in conducting GMP audits, inspections, and quality risk assessments.
2. Knowledge of GMP:
Understanding of GMP principles and practices, including documentation control, batch record review, deviations, CAPA, and validation processes.
Proficient in interpreting and applying GMP regulations and guidelines to ensure compliance.
3. Quality Assurance Skills:
Understanding of quality assurance processes, including quality control testing, quality investigations, and quality documentation.
Proficiency in risk assessment methodologies and application of quality risk management principles.
Experience in preparing for and participating in regulatory inspections and audits.
4. Communication and Collaboration:
Excellent written and verbal communication skills to effectively communicate with cross-functional teams, regulatory authorities, and external stakeholders.
Strong interpersonal skills to collaborate with colleagues at all levels of the organization and facilitate effective communication between departments.
5. Problem-Solving and Analytical Skills:
Ability to identify root causes, and propose practical solutions.
Problem-solving skills to address quality issues and implement preventive measures.
6. Computer Skills:
Proficiency in using computer software and applications relevant to quality assurance activities, such as document management systems, databases.