Qualified Person

Summary:
A Qualified Person is required for a pharmaceutical company in South Tipperary.  The successful candidate will support the Spray Dried Intermediate Drug Product and final formulated Drug Product Formulation facilities on site.

Responsibilities:

• Lead the Drug Product Intermediate and final Drug Product quality release activities.
• Ensure that the batch has been manufactured and tested in accordance with current GMP Guidelines Directive 2003/94/EC, EC Guide to GMP for medicinal products and/or the FDA Code of Federal Regulations.
• Ensure that the batch is released according to the relevant Annex to the Rules and Guidance for Pharmaceutical Manufacturers and Distributors.
• In particular Annex 13 – Investigational Medicinal Products and Annex 16 – Certification by a Qualified Person and Batch Release.
• Work with the Quality Specialist team to ensure timely and effective completion of the Quality Operations core functions, including.
• Application of Quality Risk Management to all process and systems.
• Production support and quality compliance guidance to ensure the facility meets and operates to all GMP requirements for development, clinical and commercial supply.
• Documentation preparation, review & approval to support operations.
• Prepare Annual Process and System Reviews.
• Drug substance, Spray Dry Intermediate (SDI), excipients & component release.
• Deviation management process,
• Ensure that all Laboratory Out of Specification (OOS) and process deviations are documented, assessed and associated CAPA identified.
• Provide support to deviation investigations and process performance monitoring.
• Perform trending on deviations raised as required to identify improvement initiatives.
• Ensure that root cause is identified and corrective actions are completed.
• Ensure changes controls raised are documented, assessed, and completed.
• Participate in the generation and communication of quality metrics.
• Participation in the internal audit program and hosting of external audits.
• Participate in Quality and site projects that may arise.
• Participate as a team member in the site new product introduction.

Qualifications & Experience:

• Qualified Person status achieved.
• Relevant working experience acting as Qualified Person named on a Manufacturing & Importation Authorisation (MIA) is desirable.
• Proven experience within the Pharmaceutical industry in a QA/QC/Compliance role.
• Excellent knowledge of regulations and sources of regulatory information.
• Knowledge of Quality IT systems desirable (e.g. SAP, Trackwise, LIMS, QSAT).
• Knowledge and demonstrated expertise in Lean / Continuous Improvement.
• Experience in High potency manufacturing / continuous manufacturing / Spray drying / Laboratory GMP / Project Management is desirable.
• Degree or post-graduate qualification in Science, Pharmacy or equivalent.