Description
Role Purpose
Oversee and assure Quality of the in-market quality GDP related operations in Europe CIS region in compliance with local regulations. Build the important interface between Aspen entities and national competent authorities.
Fulfils the role of Responsible Person for Aspen Pharma Ireland Limited (APIL) Unit 3016, Lake Drive, Citywest Business Campus, Dublin 24, Co. Dublin, D24 X586, Ireland, according to Good Distribution Practice of medicinal products for human use (2013/C 343/01 and regulation 45 of the Human Medicines Regulations Assure the maintenance of the associated GDP (WDA) and GMP (MIA) authorizations.
Quality Management & Assurance
* Provides direction and leadership to direct reports and other key QA Managers to enhance compliance of GMP/GDP systems in Europe & CIS region.
* Assures that the Quality Team complies with company policies and the QMS.
* Is responsible for the overall site GDP compliance in terms of HPRA requirements, company policies, procedures and all other applicable regulations and guidelines.
* Is accountable in conjunction with the Qualified Person for Pharmacovigilance (QPPV) for the overall site GMP compliance in terms of HPRA requirements, company policies, procedures and all other applicable regulations and guidelines.
* Attends the periodical Quality Management Review meetings for monitoring trends in quality parameters, Deviation and Change Control; presenting recommendations to the Pharma Affairs management to maintain process under control and/or to further improve the process.
* Presents regularly performance reviews against measures relating to the Pharma Affairs GDP related operations objectives at periodically held Quality Operations meetings.
* Ensures self-inspections are performed in adherence with an approved schedule at defined intervals and that necessary corrective actions are implemented.
* Holds overall responsibility for reporting and investigation of non-conformances and identification of CAPAs for continuous improvement.
* Approves change requests, risk assessments and action plans.
* Keeps up to date with any changes in the legislation and work seamlessly with Aspen Group personnel as it relates to Quality requirements for Europe CIS.
* Ensures that any additional requirements imposed on certain products by national law are adhered to, as foreseen in Article 83 of Directive 2001/83/EC
Computurised Systems
* Ensures that accurate records are kept and maintained in a secure manner as per Good Documentation Practice.
* Oversees the management of eQMS, LMS, QDocs, and SharePoint.
* Reviews/Approves Standard Operating Procedures and all master quality documents in relation to the operation of the GDP/GMP licences in the region
Vendor Management:
* Monitors operations of the Logistic Service Providers.
* Oversees the qualification of suppliers/service providers in the region
* Ensures appropriate transport requirements and methods for cold chain, ambient and hazardous product with the Logistic Service Provider
* Ensures that LSP/distributor audits and inspections are performed and monitors CAPA plans.
* Keeps oversight on supplier and customer bona fides.
* Approves any subcontracted activities which may impact on GDP.
* Ensures that Quality/Technical/Service Agreements are in place with all GDT related suppliers, service providers and contractors in Ireland and EU Cis markets
* Organises independent internal and external audits and inspections for assigned vendors as per the audit and self-inspection schedules.
Document and Record Management
* Is responsible for all documentation related to the area and ensures that the document management and training is managed in compliance with terms of GxP regulations and guidelines, as well as company policies and procedures.
* Ensures development, implementation and continuous improvement of GDP related processes and procedures.
* Approves deviations, change requests, risk assessments and action plans related to the area.
* Holds overall responsibility for reporting and investigation of non-conformances and identification of CAPAs for continuous improvement related to the area.
* Keeps up to date with any changes in the legislation
Training
* Responsible for creation and roll out of trainings related to GDP operations
* Ensures that EME personnel are adequately trained and that continuous training programs are maintained.
* Ensures training is periodically assessed.
Personnel
* Carries out all duties in such a way as to ensure GDP compliance.
* Functionally manages the Europe and CIS Quality Team in cooperation with the respective line managers
* Ensures that all direct reports are trained and that continuous training programs are maintained.
* Defines personal and staff roles, responsibilities and accountabilities and record all delegated duties.
* Ensures all personnel are trained in GDP, their own duties, product identification, the risks of falsified medicines and specific training for products requiring more stringent handling.
* Maintains training records for self and others and ensure training is periodically assessed
GDP/GMP Operations
* Carries out due diligence checks and ensure that GDP related suppliers and customers are qualified.
* Ensures all necessary checks are carried out and that medicinal products are authorized for sale.
* Manages authorized activities to ensure operations do not compromise the quality of medicines and can demonstrate compliance with GDP.
* Demonstratse the application of activities and provisions in accordance with the wholesale distribution authorization and of company processes and procedures.
* Ensures that any additional requirements imposed on certain products by national law are adhered to e.g. specials, unlicensed imports & controlled drugs.
* Ensures that returns handling, temperature excursions management, complaints handling, stock transfers/release are dealt with efficiently and effectively and in accordance with the Quality Technical Agreements.
* Performs waiver/out of stock-activities as required on behalf of the marketing authorization holder and notify Health authorities.
* Ensures relevant customer complaints are dealt with effectively, informing marketing authorization holder of any product quality/product defect issues.
* Decides on the final disposition of returned, rejected, recalled or falsified product
* Approves any returns to saleable stock.
* Coordinates and promptly perform any recall operations for medicinal products
* Co-operates with the marketing authorization holder and national competent authorities in the event of recalls
* Has an awareness of the issues surrounding falsified medicines.
* Ensuring of handling of medical enquiries and adverse events efficiently, effectively and aligned to Technical Agreements
* Ensures batch release/certification, deviation management, and annual product review with efficiently and effectively and in accordance with the Quality Technical Agreements
* Ensures oversight of manufacturing operations delegated to AGI is maintained in compliance with MIA requirements
Special Tasks & Authority
Responsible Person GDP (RP GDP) for Aspen Pharma Ireland Limited (APIL) Unit 3016, Lake Drive, Citywest Business Campus, Dublin 24, Co. Dublin, D24 X586, Ireland, according to Good Distribution Practice of medicinal products for human use (2013/C 343/01 and (2013/C 343/01
The authority and resources required to fulfil the responsibilities of the Head of Quality Operations Europe & CIS and Responsible Person for APIL will be provided by management. In following positions job holder is directly authorising officer:
* Responsible Person GDP
* As outlined as Power of Attorney for Aspen Pharma Trading Limited (MAH)
Requirements
* Bachelor or Master's Degree - Pharmacy or Analytical Science
* 10 years of experience in Pharmaceutical industry
* Ability to work in a complex matrix team environment and with both internal and external partners
* Advanced level of understanding of GDP & GMP regulations
* Quality Assurance & Risk Assurance - advanced skills
* Ability to interact with people across multiple functions and levels. Have considerable experience with customer negotiations
Work Level
Management
Job Type
Permanent
Salary
Market Related
EE Position
Yes
Location
Dublin