Durée indéterminée

On behalf of our client, a growing company based in Neuchâtel, we are currently looking for a

Specialist, QA Operations

Vos tâches

Duties and Responsibilities
The position holder is responsible and accountable for the tasks given below. The list of tasks is nonexhaustive, according to business needs other tasks might be assigned to the position holder.
a. Handling and preparing executed batch records and documents to make the dossiers ready for
the review by QA Operations team, contact partners, if necessary, to collect lacking
b. Ensures close collaboration with external partner to comply with Celgene’s Quality Operations
roles, responsibilities and requirements as defined in the Quality Agreements to allow smooth,
compliant and timeliness release of the products between both parties.
c. Ensures scanning of the executed batch records and QA documentation regarding the given
lead-times and due dates.
d. Ensures active participation in Tier meeting by communicating priorities, organizing lot tracking
in respect of Supply and cycle time requirement.
e. Ensures registration of exBRs and documents into the shared drives, folders and database as
f. Ensures the follow up of the QA documentation in the archive room as assigned.
g. Ensures efficient management of the QA Operations archiving areas.
h. Ensures preparation and update of the weekly planning of the executed batch records as
i. Ensures the follow up of the weekly exBRs planning for the Quality Operations according to the
production schedules.
j. Performs Lims Master Data verification and implementation of accurate Certificate of Analysis.
k. Performs regular Batch record review and release to support team
l. Supports the change control process. Performs action plan evaluation and coordinates change
control progress within assigned areas of responsibility.
m. Contributes for the external samples management
n. Assists in writing/updating Standard Operating Procedures and other quality documents.
o. Provides support to Quality Operations during audits in terms of dossier preparation.
p. Provides support in Reviewing, approving and executing the administrative destruction of
q. Contributes in the Launches’ change controls QA Support related action (Release
Documentation or associated documents). Assess specifications updates and impact on
Certificate of Analysis.
r. Provides support to Quality Operations team by performing batch record review as assigned
s. Supports the requests either from the stakeholders internally and externally as appropriate. e.g.
Regulatory request for market submission, renewal…

Votre profil

QA Operations team is committed to actively support Celgene/BMS Boudry manufacturing site and
other departments to ensure cGMP compliant production, testing and release of product.
Related to critical project with third party, the position holder is responsible for providing support
services to the external partner within the Quality Operations organisation in relation of the executed
batch records of commercial product manufactured at the Boudry site or at CMOs
The position owner must ensure strong oversight between external partner and Boudry site about
work-in-progress and release priorities using SharePoint, electronic system reporting and database.
The activity also covers different types of administrative services (reception, compilation, scanning)
of the dossier, and practical activities (e.g. handling of Samples, destruction…).
Task may include Batch record review as a support activity.
All activities are to be done in a compliant, effective and efficient manner in accordance with the
timelines and quality agreement.
As a key member of the Quality Operations team the position responsibilities includes close
collaborations with QA function and other stakeholders (e.g. Manufacturing, QC, Supply
Management, Customer Logistics).
2. Skills/Knowledge Required
• Professional certification in administrative field with minimum 1 year of administrative
• At least 1 year of experience in a pharmaceutical company or other related industry.
• Strong knowledge in computer tools Microsoft (Access, Excel, Word) and scanner software.
• Ability to work independently, yet effectively in a team-oriented environment.
• Strong sense of responsibility, reliability, accuracy and timely work.
• Ability to handle multiple tasks while working against pressures of deadlines.
• Good organizational skills capability.
• Good written and verbal communication skills.
• Sense of team spirit, initiative and servic

Date d'entrée

À convenir