Lead Quality Compliance Officer

Role Summary

This role is responsible for ensuring compliance with Quality Management Systems (including ISO 9001), GMP, GDP, and all relevant regulatory requirements across plant operations. The position involves preparing, reviewing, and submitting regulatory documentation, coordinating with authorities, managing CAPAs, change controls, risk assessments, and customer complaints, as well as reviewing and approving artworks, labeling, and packaging materials.

Key Responsibilities

• Ensure compliance with QMS (ISO 9001), GMP, and GDP standards.
• Prepare, review, and submit regulatory documentation (registrations, variations, renewals).
• Coordinate with authorities to obtain necessary approvals.
• Manage CAPAs, change controls, risk assessments, and customer complaints.
• Review and approve artworks, labeling, and packaging materials.
• Coordinate internal and external audits and maintain accurate documentation.
• Drive continuous improvement initiatives within QMS and compliance systems.

Requirements/Qualifications

• Bachelor’s degree in Pharmacy or a related Science discipline.
• Minimum 3 years of experience in Regulatory Affairs & Quality Compliance.
• Good knowledge of QMS (including ISO 9001), GMP, GDP, and regulatory requirements.
• Hands-on experience in CAPA management, audits, artwork review, and regulatory documentation.
• Strong analytical and problem-solving skills with attention to detail.
• Ability to manage multiple tasks and meet strict deadlines.
• Effective communication and stakeholder coordination skills.
• High level of accountability with a strong quality-oriented mindset.

Location

Sunshine Healthcare Lanka Ltd, No 60, Dharmapala Mawatha, Colombo 03, Sri Lanka.