QA Manager/RP for Distribution is required by our client a multinational biopharmaceutical company based in WestMeath. The company is focused on serving patients with severe and ultra-rare disorders through the innovation, development and commercialization of life-transforming therapeutic products.
As QA Manager/RP you will be required to :
o 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.
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 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.
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 Schedule periodic Quality Operations management review meetings with third parties.
o Attend the Quality Management Review meeting and participating in the review of the APIT Quality and Regulatory Compliance Policy and Objectives for continuing suitability.
As QA Manager/RP you will have:
o Academic degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering)
o Certified Responsible Person
o Minimum 5 years in international pharmaceutical and/or biotech industry with increased level of responsibility
o Minimum 2 years of experience in QA distribution and GDP
o Experience (international preferred) in managing contractors
o Sound awareness and understanding of pharmaceutical business, especially with regards to quality and regulatory requirements
o Demonstrated success records in auditing and improvement processes
o Ability to operate efficiently in a complex matrix organization and international environment
o Management skills for management of a team of experts,
Please contact Mairead on 021 4777329 for full details of this role or apply directly through this advert.