Manager QA Distribution & RP

2022-01-12 09:41:102049-05-28Team Horizon
Job TypeContractor
SectorQualitySupply Chain
Start Date
AdvertiserAshling Guthrie
Job Ref#2312
Job Views24
We are seeking applications for an experienced Manager for QA Distribution & Responsible Person for a Biopharmaceutical based in Dublin. In this role you will fulfil the Responsible Person role in relation to the Wholesale Distribution Authorization License for the distribution of Medicinal Products by or on behalf of our Client to global markets. This role is responsible for ensuring that the quality, safety and traceability of medicinal products are maintained within the company Global Supply Chain. This role is responsible for ensuring compliance to EU GxP regulations and company procedures as they pertain to distribution and ensure decisions are made with regards to the RP responsibilities.
Why you should apply:
  • Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.
What you will be doing:
  • Ensure distribution compliance with applicable regulations, the WDA, Manufacturer’s Authorization and Intercompany Agreements as they pertain to GDP & performs GDP duties respectively.
  • Provide leadership & technical expertise to the site and business partners in Global Supply Chain and commercial.
  • Ensure company is kept fully informed of new or emerging GxP/GDP & regulatory changes in their region.
  • In collaboration with Enterprise Quality, weigh and communicate quality and compliance risks as appropriate.
  • Fulfil responsibilities personally & be continuously contactable for any required communication as it pertains to the licence. RP may delegate duties but not responsibilities. The RP should carry out duties in such a way as to ensure that APIOUC demonstrates that GDP compliance are met. Keep appropriate records of any delegated duties
  • Ensuring the condition of the licence are maintained & provide recommendations to Senior Management through Quality Management Review, where APIOUC and proposing Corrective and Preventive Actions to promote compliance with the conditions of GDP.
  • Ensure the quality system is implemented and maintained in compliance with GDP requirements.
  • Ensure that accurate & legible records as required by GDP, are generated and maintained in a secure manner
  • Ensure that suppliers & customers are approved
  • Approve any subcontracted activities which may impact on GDP. Ensure  management of third parties pertaining to the licence.
  • Ensure GDP self-inspection are performed in accordance with an approved schedule at defined intervals & that any necessary CAPA are implemented
  • Lead & provide expertise for the preparation of inspection readiness activities, host inspections including acting as primary contact with inspectors, responses to inspection observations, to monitor progress of follow up actions, as required.
  • Ensure that all personnel involved in the APIOUC wholesaling activity are trained in the principles of GDP and Falsified Medicines Directive and continuous training programs are maintained and the implementation of the training programme is effective
  • Lead recall operations for APIOUC as required under the licenses and ensuring adequate supervision of recall system implemented.
  • Ensure customer complaints pertaining to GDP are dealt with efficiently and effectively
  • Ensure continuity of supply is maintained and ensuring any risk to continuity of supply is escalated.
  • Involved in the process whereby any decision is made to quarantine or dispose of returned, rejected, recalled or falsified products. Maintain oversight of the process for returned medicinal products being disposed. Approve returns to saleable stock of a returned product.
  • Ensure APIOUC obligation to the Falsified Medicines Directive is met.
  • Ensuring any additional requirements imposed on certain products by national low are adhered to, as foreseen in article 83 of Directive 2001/83/EC.
  • Maintain current knowledge of GDP legislation & undergo ongoing training as applicable.
  • Other responsibilities assigned to APIOUC RP as detailed in company procedures.
What you need to apply:
  • Academic degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering). A degree in Pharmacy is desirable.
  • Minimum 8 years in international pharmaceutical and/or biotech industry with increased level of responsibility.
  • Minimum 5 years of experience in Quality and GDP.
  • Responsible Person (RP) qualified and time spent as RP preferred.
  • Thorough knowledge of cGMPs/GDPs and global regulatory requirements
  • Sound awareness and understanding of pharmaceutical business, especially with regards to quality and regulatory requirements
  • Demonstrated success records in 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 contacts both internally and externally including with Health Authorities
  • Strong verbal and written communication skills with well-structured communication and presentation ability to various audience levels
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