- An opportunity has arisen in our client’s Quality team for an experienced Qualified Person supporting the Spray Dried Intermediate Drug Product and final formulated Drug Product Formulation Facilities.
Core Duties and Responsibilities:
- As a site SME for batch disposition, 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.
- 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.
- Work with the Quality Specialist team to ensure timely and effective completion of the Quality IPT 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.
- 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.
Minimum Qualifications and Experience:
- 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).
- Proven 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.
- The Qualified Person is a self-directed, decision maker who 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.
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
14 Danville Business Park, Kilkenny, Ireland
+353 56 77 90100
Please note, we do not require agency assistance with this role.