Quality Manager/RP

Quality Manager/RP
Our client, a Pharmaceutical R&D and commercialisation organization, are currently recruiting for a Quality Manager to join their team on a permanent basis. As Quality Manager you will ensure the companies products imported and distributed in Europe, are manufactured and distributed according to EU regulations. The Quality Manager will maintain quality compliance with Good Distribution Practices (GDP), Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs). This role will mainly be remote working with a requirement to be in the Dublin office one day per week.

Responsibilities

• Coordinate launch and post-launch shipments
• Coordinate with QPs for the timely release of batches
• Development, periodic review, revision and implementation of SOPs as required in line with EU guidelines
• Coordinate with regulatory agencies and customers for gaining and maintaining relevant authorizations, including hosting inspections and responding to observations
• Conduct monthly meetings with customers to track the pending activities and timely resolutions
• Review of change controls, deviations and CAPAs
• Participate in, and lead, relevant Quality Risk Management Assessments
• Monitor stock transfers and maintaining retained samples according to GMP
• Review of Annual product reviews and lead Quality Management Review
• Review of stability reports for compliance with EU registrations
• Schedule and carry out Internal Audits
• Implement/review quality agreements with manufacturers, wholesalers and distributors
• Ensure that bona fides are established for all customers and suppliers of medicinal products
• Conduct inspections of manufacturers distributors and wholesalers as necessary per GMP/GDP requirements
• Act as primary EU quality contact person with partners and also with subsidiaries for internal quality compliance matters
• Implement recall procedures if necessary
• Receive and conduct as required GDP/GMP training for relevant staff
• Ensure that training plans are implemented and training records are maintained
• When required, to fulfil the Company’s requirements with respect to Responsible Person responsibilities for GDP
• Support Pharmacovigilance and Regulatory Affairs as directed when required, e.g. compliance activities, co-ordinating documentation requests

• Bachelor’s degree required in a scientific disciple such as Chemistry, Biology, Pharmacy or other health related field. Graduate degree preferred
• Familiar with a variety of pharmaceutical concepts, practices and procedures and the functioning of quality assurance and regulatory affairs departments
• Hands on experience in interacting on EU quality issues
• Ability to work cross functionally within the Company and practically apply GMP / GDP and associated legislation
• Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data
• Experience of conducting audits
• Ability to assess quality risks, and where appropriate, recommend contingency plans and strategies to mitigate risks
• Detail oriented and highly organized
• Previous status of Responsible Person in accordance with the HPRA’s educational requirements, experience, training and licensing (compliance with the requirements of Directive 2013/C 343/01) is desired