LSC have an exciting opportunity for a QA Specialist in Distribution to work with our biopharmaceutical client based in Dublin. This mulitnational biopharma client is currently building a state of the art manufacturing facility for the innovation, development and commercialization of life-transforming therapeutic products to treat patients with severe and ultra-rare disorders.
The QA Specialist Distribution will act as the Deputy Responsible Person supporting the RP and will:
o Ensure the conditions of the Wholesale Dealer’s Licence are maintained.
o 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
o Reviewing and advising upon the company’s standard operating procedures in relation to the operation of the licence
o 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
o Participate in recall decision and support product recalls as required under the WDA
o Ensure adequate supervision of any product recall system implemented
o Support 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
o 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
o Ensure the review, and where appropriate, preparation and regular update of Quality Agreements and Service Agreements with licensees and 3rd party contractors
o Ensure that all records generated in relation to GDP are accurate and legible and maintained in a secure manner
As QA Distribution Specialist you will have:
o Academic degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering)
o Responsible Person Certification
o Minimum 5 years of experience in Quality Assurance Distribution and Good Distribution Practices (GDP)
o Previous experience in the capacity of a Responsible Person / Deputy Responsible Person
o Minimum 2 years in international pharmaceutical and/or biotech industry with increased level of responsibility
o Experience (international preferred) in working with a complex supply chain
Call Kathy at LSC on 021 477329 for more information on this QA Specialist Distribution – Deputy Responsible Person, or apply directly via this advert.