Quality Assurance GMDP Operations and Responsible Person Man

Contract Type: Permanent
Location: Midlands
Contact Email: laurentina@rftgroup.ie

Job Description

Quality Assurance GMDP Operations and Responsible Person Manager
The Senior GMDP Quality operations manager takes accountability for ensuring the overall compliance and fitness for purpose of the Quality System that supports manufacturing operations for IMP (comparator labelling and packaging activities) pursuant to the European Commission guidelines of December 2017 on good manufacturing practice for investigational medicinal products for human use (Clinical Trials regulations EU No 536/2014) and Importation and distribution activities for exempt medicinal products supplied for Expanded Access Programs performed under the MIA and WDA, pursuant to article 5.1 of Directive 2001/83/EC, and Good Distribution Practices (2013/C 343/01)
Key Responsibilities:
The role formally encompasses the Responsible Person role as named on the WDA in Ireland.
The role also incorporates the responsibility for line management of QA team in Ireland. As part of the broader QA team, the role requires engagement with internal and external stakeholders to promote quality in all activities and deliverables undertaken.
Pharmaceutical Quality System
Ensures the effective implementation, application and maintenance of the Global Pharmaceutical Quality System for the Ireland facility and operations;
• Has oversight of / reviews and approves deviations relating to GMP and GDP operations within Ireland
• Has oversight of / reviews and approves changes relating to GMP and GDP operations within the Ireland business
• Ensures all vendors involved in the GMP and GDP supply chain (Products, materials, components, services, Suppliers) are qualified in accordance with Vendor assurance programs.
• Ensures Supply Chain mapping is undertaken for all product supply chains. Includes, where required working with Client QA functions to include visibility of.
• Has oversight of the management of Product Quality Complaints (PQCs) resulting from supply / use of products manufactured (labelled & packed) or wholesaled
• Ensures the delivery of the Internal Audit / Self Inspection program to GMP and GDP operations and processes within the Ireland operation.
• Ensures that critical equipment, systems and processes are adequately qualified and validated for their intended use.
• Keeps current on performance of the QMS and emerging quality trends / risks such as complaints, audit findings, deviations, non-conformance, etc. through participation in global management review meetings.
• Leads the Ireland facility Quality Management Review activities.
• Keeps current on overall performance of the PQS and emerging quality trends / risks.
• Supports the establishment and development of Quality Key Performance Indicators.
• Management review - involvement
• Quality Risk Management - involvement

GMP operations (Packaging and Labelling)
• Where required, review and approval of artwork files, for printed packaging components
• Review and approval of packaging component specifications
• Ensuring systems are in place for the control of Product Specification Files
• Ensures overall compliance of labelling and packaging operations to GMP
• Review / approval of Master packaging records
• Review / approval of Batch packaging records
• Overall accountability for Quality Control activities on materials and products used in labelling and packaging operations including In Process Controls (IPCs) and finished product sampling.
GDP Operations and Responsible Person role
• Named as the Responsible Person on the Wholesale Distribution Authorisation in Ireland.
• Ensures a direct line of communication is maintained with the Deputy Responsible Person
• The following responsibilities are assumed by the Responsible Person:
•Ensuring that the quality, safety and traceability of medicinal products is maintained within the supply chain.
• Ensuring that a quality management system is implemented and maintained.
• All GDP relevant SOPs are reviewed and approved by the Responsible Person named on Ltd Wholesale Distribution Authorisation.
•Carry out their duties in such a way to ensure that GDP and public service obligations are met.
•Focus on the management of authorised activities and the accuracy and quality of records.
• Ensuring that initial and continuous training programmes are implemented and maintained.
• Coordinating and promptly performing any recall operations for medicinal products.
• Ensuring that relevant customer complaints are dealt with effectively.
• Ensuring that suppliers, customers, and outsourced contractors are approved and Bona Fide prior to use.
• Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place.
• Keeping appropriate records of any delegated duties.
• Deciding on the final disposition of returned, rejected, recalled or falsified products and ensures full understanding and management of the FMD system of falsified products.
• Approving any returns to saleable stock.
• Maintain oversight of any disposable of product using an approved outsourced provider
• Ensuring that any additional requirements imposed on certain products by national law are adhered to.
• The Responsible Person should fulfil their responsibilities personally and should be continuously contactable.
Competency/skill requirement and personal attributes for role:
• Scientific degree (including either pharmacy, pharmaceutical sciences, chemistry, biology or related) (essential).
• Impressive, demonstrable track record & skills/experience gained within similar position(s) (Management level quality roles covering GMP and GDP requirements) (essential).
• Good understanding of the pharmaceutical industry, ideally including the unlicensed (or exempt) medicines sector and Investigational Medicinal Products (IMPs)
• Working knowledge of European Commission guidelines of December 2017 on good manufacturing practice for investigational medicinal products for human use, pursuant to the second subparagraph of Article 63(1) of Regulation (EU) No 536/2014,
• Working knowledge of EudraLex volume 4 - Good Manufacturing Practice (GMP) guidelines
• Working Knowledge of Good Distribution Practice of medicinal products for human use (2013/C 343/01)
• Working knowledge of processes and systems used in the manufacture and distribution of licensed and unlicensed medicinal product. (desirable).
• Recent experience of, and knowledge of, working within HPRA licence requirements (desirable).
• Credible & confident communicator (written and verbal) at all levels (essential).
• Commercially astute & highly customer focused (essential).
• Strong analytical & problem-solving ability (essential).
• Hands-on approach, with a ‘can do’ attitude (essential).
• Strong organisational skills: ability to prioritise, with good time management skills (essential).
• Good attention to detail & ability to work accurately in a busy, demanding environment (essential).
• Ability to work with commonly used IT platforms and packages (essential).
• Strong team player (essential)
For further information on this Quality Assurance GMDP Operations and Responsible Person Manager position please contact Laurentina Kennedy at The RFT Group on 01 2302400 / Laurentina@rftgroup.ie.
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