Quality control and Regulatory Affairs

Company Description

OneGuardian Brand

Job Purpose

To ensure that all product artworks comply with approved formulations, regulatory requirements, and brand guidelines before release for printing and production. The role involves coordination between internal teams, design agencies, and manufacturing units to ensure accuracy, consistency, and compliance.

Key Responsibilities

• Review and approve artworks for labels, cartons, leaflets, and other packaging materials as per the approved master data.
• Verify product details such as product name, ingredients, claims, pack size, MRP, batch coding area, manufacturing / marketing address, regulatory symbols, and statutory declarations.
• Ensure alignment of artwork with the approved formulation, pack copy, and regulatory guidelines (Domestic & International).
• Coordinate with cross-functional teams Regulatory, Marketing, Packaging, and QA for artwork finalization and approvals.
• Maintain artwork version control and track approvals through the artwork management system or manual records.
• Communicate and follow up with vendors/design agencies for correction or update of artworks.
• Ensure artworks are approved before printing; prevent use of unapproved or outdated designs.
• Support regulatory submissions and audits by providing artwork-related documentation and version history.
• Investigate artwork-related deviations and implement corrective and preventive actions (CAPA

Qualifications & Experience

• Bachelor's degree in pharmacy / science / design / Packaging Technology or equivalent.
• 45 years of experience in artwork review in cosmetics, pharmaceuticals, or FMCG industry.
• Familiarity with labelling regulations (Drugs & Cosmetics Rules, EU/UK cosmetic labelling, etc.) preferred.

Key Skills

• Strong attention to detail and accuracy.
• Good understanding of regulatory and labelling requirements.
• Effective communication and coordination skills.
• Proficiency in MS Office and PDF review tools.
• Ability to manage multiple artworks and deadlines simultaneously.