Qualified Person

Qualified Person – Cork

An exceptional opportunity has arisen for an experienced Qualified Person to join a world-class pharmaceutical manufacturer at their advanced site in Cork. This role is ideal for professionals passionate about ensuring product quality and compliance in a dynamic, innovative environment. Offering a competitive salary and benefits package including bonus, this is a chance to take ownership of critical quality systems and play a pivotal role in the release of life-saving medicines.

The Employer
Our client is a leading global player in pharmaceutical development and manufacturing, renowned for its commitment to innovation, scientific excellence, and patient safety. With decades of expertise and a truly international footprint, they deliver cutting-edge solutions across drug substances and drug products. The company offers a collaborative culture that empowers employees to make a real difference, alongside opportunities for continuous learning, career progression, and impactful work in a highly regulated, science-driven environment.

Qualifications & Experience

• Degree in Pharmacy, Medicine, Veterinary Medicine, Chemistry, Pharmaceutical Chemistry/Technology, or Biology
• Eligibility as a Qualified Person under EU Directives
• Minimum 2 years’ practical experience in a licensed medicinal products manufacturer
• Deep knowledge of cGMP, ICH, CFR, and EU/national regulatory frameworks
• Fluency in English; strong analytical and problem-solving abilities

Responsibilities
This role ensures GMP compliance, product quality, and alignment with regulatory and business objectives. Key duties include:

• Certifying and releasing batches of APIs, MPs, and IMPs in compliance with EU GMP directives
• Leading quality oversight and promoting a Quality Culture across operations
• Managing and supporting supplier qualification and risk assessments
• Acting as primary contact for regulatory authorities and clients on quality matters
• Driving continuous improvement through policy and systems enhancement
• Participating in audits, change control, and quality investigations

Skills / Technical Competencies

• Expert knowledge of GMPs, GDP, and global regulatory guidelines
• Competence in Pharmaceutical Quality Systems, audits, and validation principles
• Ability to interpret and apply regulatory requirements effectively

Nice to Haves

• Experience within multinational manufacturing environments
• Exposure to multiple operational areas or product categories
• Familiarity with technology transfer and new product introduction

Join a forward-thinking organization that blends scientific excellence with robust quality standards to deliver truly life-changing medicines. To discuss this exciting opportunity, call (phone number removed) or apply today!