Quality Investigations Lead (Sterile Products) (80-100%)

Ophtapharm AG seeks a Lead for Quality Investigations focusing on sterile ophthalmic products in Hettlingen. The role ensures GMP compliance and drives root cause analysis across QA, Manufacturing, and Regulatory Affairs.

This position serves as a central point of contact between Quality Assurance, Manufacturing, and Regulatory Affairs. The primary purpose is to maintain strict quality standards and regulatory compliance for sterile ophthalmic products within a Good Manufacturing Practice (GMP) framework.

Responsibilities

• Direct and manage investigations into deviations and customer complaints within a sterile GMP setting.
• Determine underlying causes of issues and implement lasting corrective and preventive actions (CAPAs).
• Guarantee that all investigation records are completed accurately and in accordance with regulatory timelines.
• Work closely with cross-functional teams, including QA, production, and regulatory departments.
• Analyze data trends to continuously refine investigation methodologies and elevate overall quality benchmarks.

Requirements

• University degree in Life Sciences, Pharmacy, Chemistry, or a closely related discipline.
• Minimum of five years of professional experience conducting quality investigations in sterile GMP manufacturing environments.
• Comprehensive understanding of GMP regulations and specific FDA requirements applicable to sterile products.
• Demonstrated proficiency in performing root cause analysis and managing the CAPA lifecycle.
• Fluent command of both English and German languages.

What the company offers

• Significant autonomy to define and enhance investigation workflows.
• A dynamic environment where employee contributions directly influence company evolution.
• Direct engagement with leadership and opportunities for cross-departmental influence.
• A supportive team culture that emphasizes shared responsibility and collaborative problem-solving.
• Flexible work arrangements and a stable, comprehensive employment package.

About the company

Ophtapharm AG operates as a certified manufacturer of ophthalmic pharmaceuticals, adhering to both FDA and EU-GMP standards. The company specializes in the aseptic production, filling, and packaging of high-quality eye drops, ointments, and gels for global distribution.

• FDA and EU-GMP certified manufacturing operations.
• Focus on aseptic production of eye drops, ointments, and gels.
• Service to international markets with high-quality standards.