The Quality and Operations Analyst is responsible for the execution of all Q1 Scientific QMS and Operations activities.
Responsibilities
Reporting to: The Quality Lead.
Main responsibility:
The Quality and Operations Analyst is responsible for verifying that quality is being maintained throughout the stability storage and sample management process. The person is also responsible to receive the samples and to participate the stability storage management, together with the management of the facility and its equipment.
Specific responsibilities include but are not limited to:
QMS:
Provision of assistance and advice to the Company on all QMS activities.
Ensure that all Q1 activities meet the quality standards specified by the Company QMS and in accordance with cGMP and GDP standards.
Continually monitors the QMS system suggesting improvements and CAPA measures.
Provision of assistance for administration of quality manuals, continuous improvement initiatives & interaction with management personnel on quality initiatives.
Performing investigation for all CAPA following planned and unplanned deviations, quality events.
Audits:
Ensure compliance to GMP and GDP certification by provision of assistance in reporting internal reviews.
Participate to all internal, regulatory, supplier and customer audits.
Operational Activities:
Administration of quality and operations documents, continuous improvement initiatives and interaction with management personnel on quality and operations topics to include but not limited to:
Providing admin assistance to the Company on all QMS activities issuing controlled documents (logbooks, protocols for execution, etc.).
Maintenance of indexes (electronic and hard copy)
Review of completed documents for compliance to specification and to ensure all entries are complete.
Proposing/reviewing document changes as appropriate.
Checking off second signature for Operations as appropriate.
Performing daily checks on stability cabinets/room conditions as appropriate
Providing support as required for checking of samples on receipt at Q1 Scientific/on return to Client as appropriate.
Providing general admin support as required.
Facilities Management :
Provision of assistance for the cleanliness of the facility and compliance with equipment and maintenance schedules, in line with the quality management system.
Be available in case of urgent interventions at the facility out of normal working hours (repairs, breakdowns, …)
Assist in the development, optimisation and validation of new equipment.
Contribute to extension projects of the facility
Order consumables and maintain sufficient quantities of office supplies and sundries.
General Office Administration :
Answering telephone calls and emails and dealing with problems in a timely manner.
Maintain administrative records, including invoices, delivery notes and contractor reports.
Liaise with external consultants and contractors.
Backup role :
Act as backup of the Quality Lead, the Operations Lead and the Stability & Operations Analyst.
This is not an exhaustive list of duties, and you will be expected to perform different tasks as necessitated by your changing role within the organisation and the overall business objectives of the organisation.
