Manager QA Distribution And Responsible

Pe Global

Dublin

PE Global are currently recruiting for a Manager QA – Distribution for a client site in Dublin- Principal Responsibilities. Ensure the conditions of the Wholesale Dealer's Licence are maintained by providing recommendations on where the company is potentially or actually in breach of the licence and making suggestions as to the steps to be taken to ensure compliance with the conditions of the Good Distribution Practice. Ensure that the operations do not compromise the quality of medicines by ensuring that systems are in place to monitor storage of the product through the supply chain under the control of the company. Reviewing and advising upon the company's standard operating procedures in relation to the operation of the licence. Ensure audit of the quality system is completed on a regular basis by periodic review of QMS and operational procedures for regulatory compliance through internal audit system. Participate in recall decision and support product recalls as required under the WDA. Ensure adequate supervision of any product recall system implemented. Ensure the preparation, implementation and on-going maintenance of the QMS systems and operational procedures, policies and other related documentation, in compliance with applicable legislation, regulations and regulatory guidance. Ensure the management of third parties (CMOs and affiliates) including regular review and auditing of their Quality Management Systems either by personnel or through the management of audits contracted to qualified third parties, to ensure compliance with applicable legislation and regulations. Ensure the review, and where appropriate, preparation and regular update of Quality Agreements and Service Agreements with licensees and 3rd party contractors. Schedule periodic Quality Operations management review meetings with third parties. Attend the Quality Management Review meeting and participating in the review of the APIT Quality and Regulatory Compliance Policy and Objectives for continuing suitability. Ensure any subcontracted activities which may impact on GDP are approved and that suppliers and customers are approved. Ensure that customer complaints are dealt with efficiently and effectively. Ensure continuity of supply is maintained. Decide on the final disposition of returned, rejected, recalled or falsified products. Ensure returns to saleable stock are approved. Be contactable by the HPRA the Competent Authority at all times and provide the HPRA with the appropriate contact details. Ensure that any additional requirements imposed on certain products by national law are adhered to, as foreseen in Article 83 of Directive 2001/83/EC. Ensure appropriate records of delegated activities are kept. Ensure necessary self-inspection corrective measures are put in place. Any other duties as required by management. Qualifications: Minimum 5 years in international pharmaceutical and/or biotech industry with increased level of responsibility. Minimum 2 years of experience in QA distribution and GDP. Experience (international preferred) in managing contractors. Sound awareness and understanding of pharmaceutical business, especially with regards to quality and regulatory requirements. Demonstrated success records in auditing and improvement processes. Ability to operate efficiently in a complex matrix organization and international environment. Management skills for management of a team of experts, Strong mature leadership and interpersonal influencing skills. Ability to represent the company and to negotiate at different levels contacts both internally and externally. Strong verbal and written communication skills with well-structured communication and presentation ability to various audience levels. Education: Academic degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering. Certified Responsible Person. Interested Candidates should send their CV to Audrey.brennan@peglobal.net or call 0214297900. Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. This job originally appeared on RecruitIreland.com.

2106 days ago