Reporting to the principal consultant, the primary responsibility of the compliance and quality associate is to prepare and compile, 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.
Key Responsibilities:
1. Coordinate with clients and ensure their operation is compliant with applicable acts and regulations.
2. Review all batch releases and create batch records packages (asset).
3. Assist with the preparation of licensing applications associated with cannabis, food, and related industries in Canada and the USA.
4. Ensure that all SOPs and specifications for each procedure are appropriate and followed by the concerned personnel.
5. Review the batch records and release products in accordance with all applicable SOPs and regulations.
6. Conduct internal inspections and gap assessments.
7. Ensure that appropriate manufacturing in-process controls are implemented.
8. Review all documents that describe work instructions and set requirements such as procedures, protocols, test methods, specifications, etc.
9. Ensure all non-conformances, customer complaints, and out-of-specifications are investigated, and root causes are found.
10. Perform employee training for GMP, SOPs, and new positions as required by the client.
1. Candidates with minimum 2 years of experience.
1. Experience in quality assurance activities, and review of batch release documents. Must have experience in the food industry or related industries.
2. Experience working with the FDA and/or Health Canada is a must.
3. Post-secondary education preferably in regulatory affairs or 2-5 years of regulatory affairs/quality assurance experience in the pharma or medical device industry.
4. Knowledge of ISO, Health Canada, FDA, and European Device standards.
5. Knowledge of MDL, MDEL, NHP, SFCR, drug facility registration, drug label compliance, and others.
6. Proficiency in written & and spoken English.
7. Skills and knowledge to keep all lines of communication open.
8. Strong interpersonal and organizational skills.
9. Excellent computer literacy.
10. Ability to work independently.
11. Team player who thrives in a busy environment with multiple priorities.
12. Attention to detail (critical).
13. Ability to work in a start-up culture.
Annual CTC: ₹ 5,00,000 /year
CanSat Consulting Inc. is a trusted consulting firm that provides affordable services in licensing, quality, and regulatory compliance. We cater to the needs of food, natural health products, dietary supplements, and medical devices. At CanSat Consulting, we understand the fine intricacies of complex regulatory frameworks around various acts and regulations.
