Looking to hire Compliance and Quality Associate

Nature & Scope of Position

• Reporting to the Principal Consultant, the primary responsibility of the Compliance and Quality Associate is to prepare licensing applications, research Acts and Regulations, review batch records, write non-conformance and CAPA reports, and coordinate with clients and others.

• The candidate must have strong communication and interpersonal skills and must hold to the highest level of integrity and confidentiality. The successful candidate depending on their skills, experience, and performance would also have the opportunity to take part in profit sharing.

General Duties & Responsibilities

• Coordinating with clients and ensuring their operation is compliant with applicable acts and regulations.

• Assist with the preparation of licensing applications associated with Food, and pharmaceutical industries in Canada and the USA.

• Ensure that all SOPs and specifications for each procedure are appropriate and followed by the concerned personnel.

• Review the batch records and release products in accordance with all applicable SOPs and regulations.

• Conduct internal inspections and gap assessments.

• Ensure that appropriate manufacturing in-process controls are implemented.

• Review all documents that describe work instructions and set requirements such as procedures, protocols, test methods, specifications, etc.

• Ensure all non-conformances, customer complaints, and out-of-specifications are investigated, and root causes are found.

• Perform employee training for GMP, SOPs, and new positions as required by the client.

Knowledge, Experience & Education

• Experience in preparing regulatory filings and licensing applications in one or more of the following areas (medical devices, dietary supplements, food, pharmaceutical) is a must.

• Experience working with the FDA and/or Health Canada is a must.

• Post-secondary education preferably in regulatory affairs or related experience.

• 2 - 5 years of regulatory affairs/Quality Assurance experience in pharma or medical device industry.

• Knowledge of ISO, Health Canada, FDA, and European Device standards.

• Knowledge of MDL, MDEL, NHP, SFCR, Drug facility registration, drug label compliance, and others.

• Must be proficient in written & and spoken English.

• Skills and knowledge to keep all lines of communication open.

• Strong interpersonal and organizational skills.

• Excellent computer literacy.

• Ability to work independently.

• A team player who thrives in a busy environment with multiple priorities.

• Attention to detail is critical.

Work Environment:

• Thrive in an intense, do-it-yourself, start-up environment

• Ability to work well within a cross-functional team environment and diverse communities

Egészségügy Egészség Táplálkozástudomány Biológia Mikrobiológia

Projektazonosító: #37171408

A projektről