Qualified Person

An exciting opportunity for a Pharmacist / Qualified Person to join a leading sterile pharmaceutical manufacturing site within a global organisation.

The site is a European Centre of Excellence specialising in the development, filling and finishing of biological products for clinical trials, across vials, syringes and cartridges.

Key Responsibilities

• Oversee the validation, management and monitoring of raw materials
• Confirm and certify customer batches manufactured on site
• Manage deviations, CAPAs and quality investigations
• Support customer relationships regarding quality issues and deviations
• Ensure compliance with GMP, site procedures and quality requirements
• Approve and sign key quality documentation within QP responsibilities
• Support regulatory and customer audits
• Work closely with Production, Quality, Validation, Metrology and Maintenance teams
• Support continuous improvement of the site's Quality Management System
• Support customer complaints and related investigations

Requirements

• Pharmacist with a Master's degree (Bac +5)
• 3+ years' experience in a similar pharmaceutical Quality/QP role
• Experience with process qualification and validation
• Strong knowledge of GMP and pharmaceutical regulations
• Experience with deviations, CAPAs and quality investigations
• Sterile manufacturing experience is advantageous
• Strong knowledge of pharmaceutical quality and qualification
• Fluent English and French is a necessity
• Strong communication, analytical and organizational skills
• Ability to manage external stakeholders effectively