Senior Officer - EU QMS

Providing SAP support for UK/EU Invoices
Responsible for the EU E-Learning system and act as an Aspire admin for EU QMS training
Supporting the EU Document Management system
Supporting the Supplier Management system by:
Managing the supplier audit programme for EU, CQA and CZ product, and
Support the qualification program by performing vendor checks
The initiation, updating and maintenance of Quality Technical Agreements
EU Safety Variation Tracking
Responsible for the preparation of European KPIs for Audits, Technical Agreements and Supplier Qualification where relevant.
Backup to other QMS as needed.
Responsibilities related to SAP related support:
Process QA invoices for the UK/EU affiliates
Maintain tracker of all invoices raised and MIGO’d
Ensure proper communication with finance to close invoices on time
Manage the uploading of documents and training materials into Aspire and assign training to EU, GPD and GSSA employees. Also responsible for monitoring and oversight of training activities in all European affiliates (Glenmark Europe)
Supporting the management of EU and local documentation system (through Procedural Document Index) and coordinate/supervise the periodical revision of SOPs within the defined timelines
Supporting the implementation and further development of the Supplier Management and qualification system according to Glenmark´s policies and procedures, by initiation, updating and maintenance of:
Supplier Audit programme (Audit schedule, tracking of Audit reports and related CAPA completion)
Liaise with the partner, Glenmark´s European function across Europe to ensure that Audits and Supplier Qualifications are performed in time and in compliance with Glenmark’s and regulatory requirements for EU, CQA and CZ product and process vendors.
Supplier Qualification support by performing GMP/GDP/ISO checks on Vendors
Prepare, review and monitor the quality technical agreements throughout Europe.
Prepare the quarterly safety variation report for the Pharmacovigilance QMR based on RA variation implementation dates and release data from IH and CMOs
Preparing the monthly and annual key performance indicators (KPIs) for the UK and European Quality Systems