Job Title:
Qualified Person
Job Description:
* The Qualified Person (QP) is responsible for ensuring all products certified have been manufactured in accordance with the requirements of its marketing authorisation/ CTA and are in compliance with cGMP requirements.
* Routinely monitoring the company's operations to ensure compliance with site licenses and Good Manufacturing Practice bringing any critical and major deficiencies to the attention of the Head of Quality Assurance.
* Participate in management reviews of process performance, product quality and of the quality management system in order to identify and action opportunities for continual improvement.
* Reviews and approves Product Quality Reviews
Required Skills and Qualifications:
* Direct experience of GMP management within a pharma/biopharma company is essential, and will include exposure to FDA, HPRA or other authorities of similar standing.
* Biologics manufacturing experience highly desirable Experience in Sterile Manufacturing and/or Clinical Trials Regulations highly desirable
* High level technical skills including analytical, auditing, pharmaceutical manufacturing, and regulatory inspection management.
* Technical writing skills required.
* Expertise in GxP and global regulatory requirements Excellent training/mentoring experience Excellent oral and written communication skills Competent problem solving, risk assessment and impact analysis abilities.
Benefits:
* Competitive salary
* Aseptic / Sterile Drug Product manufacturing experience desirable Experience with IMP's (Investigational Medicinal Products) desirable
* Experience with participation in regulatory inspections, presenting or defending departmental functions in audits or regulatory inspections.
* Understanding and familiarity with European/ FDA regulatory requirements, guidelines, and expectations.
Others:
* Maintain knowledge up to date with respect to the current Good Manufacturing Practices (cGMP), technologies and quality systems for the products they certify