Qualified Person Lead

Main purpose of job:

The role is to implement and execute tasks relating to QP duties and certification activities associated with manufacturing processes/activities performed under PCI Ireland IMP, MIA and veterinary licences. This role is a Senior QP role and will take a lead role in PCI Ireland QP oversight, advising QP's on site and being a point of escalation for the QP group.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Maintain compliance with GMP and customer expectations as defined in Quality Agreements, HPRA/Ireland legal framework, HPRA licences and EU GMP Directives/Guidelines.
• Participate in regular meetings with customers to ensure current business needs are fulfilled and support continuous improvement projects including new product introductions.
• Suport the sites clinical and commercial activities including Third Party release.
• Review Batch Manufacturing Documents to ensure compliance with EU GMP and the Product Specification File/marketing authorisation (or other where relevant).
• Review Batch Documents for all operations performed at PCI Pharma Services (PCI).
• Certify Medicinal Products for use in the EU and outside the EU (where relevant).
• Undertake audits in EU and third countries to ensure that Sponsor or MA Holder manufacturing sites are operating in general compliance with EU GMP.
• Provide advice and guidance to PCI staff and Customers regarding QP requirements within the EU.
• Keep up to date with the requirements of the national regulatory authorities across the EU and rest of world (where relevant).
• Review PCI Project Files (PSFs, commercial project files etc) to ensure compliance with the current regulatory requirements and PCI procedures.
• Provide input and assistance with relevant elements of the Quality Management System (QMS) at PCI.
• Assist with regulatory inspections and client audits.
• Agree and work towards achievement of personal development goals.
• Where required, undertake departmental tasks and projects outside the job holder's area of responsibility in line with departmental and senior management team objectives.
• Identify and support opportunities for improving internal processes and or procedures
• Support training needs across the site for Commercial and Clinical Activities.

Regulatory/Industry Responsibilities

• Eligible to act as a Qualified Person (QP) for the certification of Marketed Products and Investigational Medicinal Products in accordance with both EU directives (2001/83/EC and 2001/20/EC) and local HPRA legal requirements.

Experience /Qualifications:

Required:

• Experienced in QP certification activities associated with investigational and commercial medicinal products.
• Experienced in sterile dosage and non-sterile dosage forms.
• Experienced in large molecule biopharmaceuticals.
• Experienced in EU GMP audits (QP audits) of third country manufacturing and testing facilities.
• Demonstrable experience of packaging and processing activities within the pharmaceutical or medical device industry.
• High level knowledge of GxPs across the pharmaceutical industry for both investigational and commercial medicinal products.
• Good knowledge of Quality Management Systems and principles.

Preferred:

• Experience in the review of deviation investigation and use of applicable investigation tools.
• Experienced in working across multiple facilities as part of a global organisation.
• Experience in internal and external manufacturing environments.
• Commitment to Quality Assurance principles and passionate champion of delivering strong Quality culture.
• Analytical approach / focussed attention to detail.
• Self-motivated and organised.
• Persuasive with demonstrated ability to influence internal and external stakeholders.
• Continuous Improvement methodology
• Risk Analysis principles and associated methodology

Skills / Aptitude / Personal Qualities

• Good interpersonal skills, ability to interact with cross-functional teams and internal/external stakeholders.
• Ability to prioritise work and handle competing business needs.
• Good written communication skills / Good numeracy / literacy.
• Good teamworking skills with ability to direct and influence team members.
• Ability to develop team members through coaching, mentoring and training of staff as required.