Qualified Person, 3rd Party Commercial
Dublin, Dublin North
Qualified Person Department: 3rd Party Commercial Quality. I. POSITION SUMMARY: Reporting to the Associate Director of Third Party and Commercial Quality, this individual will be responsible for performing key Quality responsibilities with respect to Third Party Contract Manufacturing Organisations (CMO’s. As the QP the primary role is to certify batches of medicinal products prior to release for sale or distribution. II. PRIMARY JOB RESPONSIBILITIES: Primary duties and responsibilities of the position are as follows. Other duties may be assigned. • Act as Qualified Person in accordance with article 51, EC directive 2001/83/EC, 2003/94/EC principals and Guidelines of Good Manufacturing Practice for Third Party and Outsourcing activities and subsequent amendment(s. • Act as Qualified Person for Certification and Release of Investigational Medicinal Products in accordance with 2001/20/EC. • Ensure Health Product Regulatory Authority licences are maintained and adequately reflect the activities of the QP office. • Act as QP representative for regulatory inspections where necessary. Where appropriate communicate directly with Regulatory Agencies. • Assist CMO operations in the preparation for regulatory agency inspections, provide support for coordinating responses and ensures commitments are maintained (as required. • Carries out assigned external audits and executes assigned activities associated with the Third Quality Management Program. • Identify industry trends and implementation strategies to keep facility ahead of compliance curve within budgetary requirements. • Ensure that appropriate policies, procedures and associated documentation are in place and in line with HPRA, EU, US and other relevant GMP requirements to support product certification and release activities of Third Party Products (OOS, investigations, deviations, CAPAs, complaints and change control etc...) • Develop, implement and continuously improve Third Party Quality management systems to comply with the changing landscape of the regulatory compliance environment. • Ensure key performance indicators associated with TPCQ activities are tracked, trended and presented to management regularly. • Identify and prioritize QP resource requirements based on finite supply chain plan and allocate and schedule resources to meet requirements and maximize productivity. • Work in close collaboration with peers to coordinate the execution of production plans and to resolve escalated issues to ensure operational efficiency in meeting planned goals. • Ensure all Quality reports are current, accurate, and distributed according to defined procedures. • Ensure continual improvement of all Quality related documentation (SOPs and On the Job aids) and that they are current, accurate, and clearly define process and role responsibilities. • Provide quality and regulatory guidance and leadership to where needed to effectively deal with compliance issues in a timely manner. • Be a primary point of contact for site regulatory, compliance and quality issues. III. ADDITIONAL JOB RESPONSIBILITIES: • May lead cross-functional initiatives and projects. IV. POSITION QUALIFICATIONS: Education: • Bachelor’s Degree or above in Chemistry, Pharmacy or related Science. 3-4 years experience in QA and batch release or review of batches and be qualified or about to recieve the qualifications to be a QP. Experience: Satisfy the minimum qualification requirements as laid down in the Directive 2001/83/EC article 49 to 52 and also the requirements as defined in the following directives: 1. EU Directive 2001/83/EC (the Pharmaceutical Directive) (Human Medicines), amended by Directives 2004/24/EC and 2004/27/EC. 2. EU Directive 2003/94/EC (Good Manufacturing Practice (GMP) for medicinal products for human use. 3. EU Directive 2001/20/EC (implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. 4. The Rules Governing Medicinal Products in the European Community, Volume 4: Medicinal products for human and veterinary use: Good manufacturing practices. 5. Eudralex Volume 4 – Good Manufacturing Practices, Annex 13 – Manufacture of Investigational Medicinal Products, Annex 16 – Certification by a Qualified Person and Batch Release. • At least 10 years relevant GMP experience. • Good understanding of manufacturing operations. • Demonstrated success in managing a team in a pharmaceutical production environment and providing leadership for all activities across the site QA operations an advantage. • Experienced in aligning individuals and teams to business objectives. • Experience in managing by metrics. • Working knowledge of manufacturing practices such as Lean, Six Sigma, Theory of Constraints, and System for Management. Licensure/Credentials: n/a. Knowledge and Skills: Computer literate; proficiency in using Microsoft Office suite; effective and clear verbal and written communication skills. . Demonstrated behaviors: • Exhibits a high personal drive for excellence and holds self accountable for consistently high-quality performance results. • Models open communication and information-sharing, consistently keeping all stakeholders informed of deliverables. Demonstrates ability to collaborate with colleagues across other functions and sites and use influence positively and skillfully to find common ground in order to achieve organizational goals. • Uses experience, technical expertise, and established standards and methods to analyze and solve problems and exercises sound judgment about when to take action and when to escalate issues to the next level of expertise. • Adapt at evaluating, planning, and prioritizing own work, creating efficient workflows to manage multiple activities and using time and resources effectively to deliver results on or before deadline. • Understands and supports the need for change and continuous process improvements. • Demonstrates the desire and ability to grow own capabilities by seeking out and engaging in challenging learning opportunities that enhance contribution to site and advance professional and career development. • Demonstrates a personal commitment to site safety by actively fostering a safety culture and upholding all safety standards in the performance of job duties. This job originally appeared on RecruitIreland.com.
68 days ago