This is a 12 month contract
The Qualified Person is responsible for the management and oversight of the Quality Management Systems in the Drug Product Intermediate and final Drug Product Formulation facilities and for the achieving the Quality deliverables in the Integrated Process Teams (IPTs) ensuring that the site meets all Manufacturer’s Licence requirements for clinical and commercial production and is audit ready for both customers and agency inspections
• 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.
• Ensure that the principal manufacturing and testing processes have been appropriately validated and that account has been taken of the actual production conditions and manufacturing records.
• 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.
• Assist the IPT leadership team to deliver business results for the IPT in line with overall site goals.
• Documentation preparation, review & approval process required to support IPT operations.
• Prepare Annual Process and System Reviews.
• Drug product Intermediate raw material (API, SDI and excipient) and component release, targeting.
• 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.
Provide detailed knowledge of quality systems and ensure that root cause is identified and corrective actions as appropriate are completed.
Provide guidance on quality requirements to maintain validation status, including participation in process/product Risk Assessments.
• Ensure changes controls raised are documented, assessed and completed.
• Participate in the generation and communication of quality metrics.
• Preparation, review & approval of site documentation including policies, procedures, associated reports, and annual reviews, as required to support site quality systems.
• Participation in the internal audit program.
• Participate in the preparation for and hosting of regulatory and customer audits.
• Participate in Quality and site projects that may arise.
• Participate as a team member in the site new product introduction teams established to manage the transition of new products from Phase II through to PPQ and supply.
• Delegate for the Associate Quality Director as required.
• Degree or post-graduate qualification in Science, Pharmacy or equivalent.
• Qualified Person status achieved with relevant working experience acting as Qualified Person named on a Manufacturing & Importation Authorisation (MIA).
• 6-8 + years’ experience within the pharmaceutical industry in a leading 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, Quality Docs).
• Knowledge and demonstrated expertise in Lean / Continuous Improvement.
• Experience and knowledge of GMP Requirements for Electronic/paper free operations.
• Experience in High potency manufacturing / Spray drying / Laboratory GMP / Project Management is desirable.
• Responsible for providing leadership and guidance on site-wide quality assurance and regulatory compliance.
• Team Leadership: supports the development and performance of the Quality Specialists in the IPT Quality team.
• Leads the IPT team in complex investigations, inspection readiness in line with appropriate inclusion principles & behaviours.
• Teamwork skills: Interacts with people effectively. Able and willing to share and receive information.
• Sets and maintains high performance standards. Pays close attention to detail, accuracy, and completeness.
• Excellent written and oral communication and interpersonal skills. Organizes and delivers information appropriately.
• Adapts to changing work environments, work priorities, organizational needs and diverse people.
• Motivation: Displays energy and enthusiasm. Maintains high level of productivity and self- direction.
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