Compliance and Quality Associate

Job Title: Compliance and Quality Associate

Location: Remote working from India

Timings: Monday to Friday (6:00 PM to 3:00 AM IST/ 8:30 PM to 5:30 PM ET) with every second Saturday working. Hours might vary depending on the Time Zone. Extended hours may be required to work, depending on the workload.

Salary: INR 35,000 to 40,000

Business

Our client is a recognized international recognized name in the field of consulting with headquartered in Canada and expanding in USA and other countries. Our client offers experienced and affordable quality, regulatory, and licensing consulting firm. We cater to the needs of Psychedelics, Food, and other related industries. Our client understands the intricacies of a complex regulatory framework around various acts and regulations and aim to provide the best services to our clients to meet their compliance needs.

Nature & Scope of Position

• Reporting to the Quality Assurance and Regulatory Associate and Principal Consultant, the primary responsibility of the Compliance and Quality Associate is to prepare and compile, review batch records, prepare sampling and testing records, review certificate of analysis, 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.
• The applicant must have 2+ years of experience in writing SOPs, protocols.

General Duties & Responsibilities

• Coordinating with clients and ensuring their operation is compliant with applicable acts and regulations.
• Ensure that all SOPs and specifications for each procedure are appropriate and followed by the concerned personnel.
• Prepare SOPs in compliance with the Regulations.
• 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.
• Investigate non-conformances, customer complaints, and out-of-specifications, and close them off.
• Perform employee training for GMP, SOPs, and new positions as required by the client.

Why Join Our Team?

• Work Remotely with Flexibility – Remote work while saving time on commuting.
• Grow Your Career with a Globally Recognized Firm – Gain valuable experience working with an internationally recognized company in the regulatory sector.
• Learn from Industry Experts – Expand your knowledge in the regulations across Canada, the U.S., Germany, Portugal, and other key markets.
• Ongoing Training & Development – Access continuous learning opportunities through specialized training programs.
• Paid Vacation – Recharge with paid time off.
• Performance-Based Profit Sharing – Unlock the potential for additional earnings through profit-sharing opportunities tied to your contributions and success.

Knowledge, Experience & Education

• 1-2 years of experience in Quality assurance activities and review of batch release documents. Must have experience in the Pharmaceutical, or Food industry. Experience working with the FDA and/or Health Canada is an asset.
• Strong communication skills and sharp attention to detail are essential for this role and will be evaluated during the interview process. You must be confident in public speaking.
• Post-secondary education in regulatory affairs, food science, pharmaceutical sciences, or Biotech.
• Strong interpersonal and organizational skills with excellent computer literacy and ability to work independently.
• Must have strong writing, communication, and interpersonal skills to be able to talk to multiple clients.
• Manage multiple clients and their documents with confidentiality and integrity.
• A team player who thrives in a busy environment with multiple deadlines and priorities.
• Must be proficient in written & and spoken English.

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

How to apply:

Our Company (Confidential) is a proud equal opportunity employer committed to an inclusive work environment and to building a team that reflects the rich diversity of our community. People of color, people with disabilities, and people of diverse sexual orientations, gender expressions, and identities are encouraged to apply.

To apply, please submit your resume and a cover letter to Applications will be accepted and reviewed until the position is filled.

Job Type: Full-time

Pay: ₹35, ₹40,000.00 per month

Benefits:

• Work from home

Experience:

• Batch Release: 2 years (Required)
• Food industry: 2 years (Required)
• Quality assurance: 2 years (Required)

Language:

• English (Required)

Shift availability:

• Night Shift (Required)

Work Location: Remote