QA Specialist - Distribution

Pe Global

Dublin

PE Global are currently recruiting for a Quality Assurance Specialist – Distribution for a client site in Dublin- Principal Responsibilities. Responsible for QA oversight of cold chain activities in all markets in accordance with local and international requirements and planning schedules; ensure products shipments are managed in accordance with GDP requirements. Assess cold chain shipments and provides corresponding quality decision on product. Act as primary QA technical contact point with distribution partners. Provide guidance, drive and monitor Quality issues related to cold chain and GDP to resolution within the company and with external parties. Review documentation including change controls, deviations, validation documentation, SOPs and specifications relating to distribution activities. Contribute to the maintenance, review and update of Standard Operating Procedures for Quality Assurance and Distribution related activities ensuring compliance with GDP regulations. Ensure Quality Agreement with client’s distribution contractors and carriers are established and maintained. Provide Quality support and oversight for Distribution Operation review meetings with Distribution contractors. Contribute to defining standard quality KPIs and to review quality indicators with recommendation for actions for improvement in relation to GDP contractors. Support the preparation of Health Authorities inspections and provide support for regulatory submissions. Ensure the conditions of the Wholesale Distribution Authorisation are maintained. 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 the review, and where appropriate, preparation and regular update of Quality Agreements and Service Agreements with licensees and 3rd party contractors. Ensure that all records generated in relation to GDP are accurate and legible and maintained in a secure manner. Ensure any subcontracted activities which may impact on GDP are approved and that suppliers and customers are approved. Ensure that customer complaints are processed efficiently and effectively. Have sufficient knowledge on the products the clien distributes and on the complexity of the operation. 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. Skills and Experience. Minimum 5 years of experience in Quality Assurance distribution and Good Distribution Practices. Previous experience in the capacity of a Responsible Person / Deputy Responsible Person an advantage. Minimum 2 years in international pharmaceutical and/or biotech industry with increased level of responsibility. Experience (international preferred) in working with a complex supply chain. Experience with engaging, influencing and supporting market affiliates. Previous experience in Shipping Validation an advantage. 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. Strong mature leadership and interpersonal influencing skills. Ability to represent the company and to negotiate at different levels 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. Responsible Person Certified desirable. 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.

2109 days ago