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Senior Manager QA operations JSC Beerse

Senior Manager QA operations JSC Beerse

Locations: Beerse, Belgium
Functions: Quality Assurance
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Job Description

Requisition ID: 1905722623W

We are looking for an employee that is having a passion for quality and loves to operate in a very dynamic pharmaceutical production environment. We are looking for an employee that likes to work with people, is connecting easily with our different business partners and is getting a lot of energy of developing our young talent.
Job Description:

Leads and manages the Quality Operations team to assure the safety, efficacy and timeliness of product supplied to patients via the deployment of suitably qualified / validated manufacturing, testing, distribution and management processes, and to satisfy all internal and external regulatory expectations

At the JSC BEE site, different product types are being produced and released such as Steriles, Liquids & Creams and Transdermals. The site in Olen, where pellet formulations are being produced, is falling under the same entity/management responsibility.
* Through collaboration with Production, Maintenance, Qual/Val, QC and Quality System personnel, lead the QA Operations team as an "expert resource" in assessing and maintaining quality and compliance levels
* Continuously challenge the status quo and lead the development and implementation of breakthrough initiatives that deliver sustainable improvement in organizational and quality performance
* Is part of the site Quality Leadership Team and is represents Quality JSC group on different forms, steering committees and task forces
* Ensure development, improvement and management of a robust and efficient quality release process, complying with internal as external regulatory requirements and is supporting the business needs
* Continuity of supply: interface daily with Planning, Manufacturing, Packaging, QC and Supply Chain groups to assure that adequate resources are available to support the twin goals of customer service and inventory minimisation, report on resources issues and operating constraints
* Manage the writing and/or QA approval of GMP documents (work instructions, SOPs, …) to ensure QA oversight of the operational activities
* Ensure and manage timely execution of the quality systems processes (e.g. NC/CAPA, CC, complaints …).
* Ensure that deviations (incl. complaints) with possible impact on quality, compliance and registration, are evaluated (incl. escalated where required), and that adequate corrective and preventive actions are implemented to continuously improve the quality system
* Support the preparation, execution by acting as host and follow-up of internal and external inspections
* Ensure and support that the internal audits are executed and reported according to internal audit schedule
* Manage, coach and develop the team in reaching their quality, business and personal objectives, empower and enable the managers and their teams
* Establishing and maintaining effective working relationships with the different business partners at both site level and at global level

* University degree, scientific orientation (pharmaceutical, chemical or biological sciences/engineering)
* 10 years' experience in pharmaceutical industry (ideally with a mix of production, QA/QC expertise)
* In depth understanding of pharmaceutical production (manufacturing and packaging) and the specific technologies that are being applied, qualification, validation, testing, release and distribution processes
* Thorough knowledge of pharmaceutical legislation, in cGMP regulations (domestic & international), ICH guidelines, policies, standards and procedures
* Have been exposed to Health Authority inspections such as EMA and FDA
* Strong analytical thinking, risk assessment, managerial and leadership skills
* Ability to provide operational leadership to meet business objectives in a highly dynamic business environment
* Excellent communicator, ability to building a network and create win-win solutions
* Understands the business implications regarding quality positions and decisions
* Experience in sterile manufacturing environment is an asset

Primary Location
Janssen Pharmaceutica N.V. (7555)
Job Function
Quality Assurance
Requisition ID

Senior Manager QA operations JSC Beerse

Permanent contract
Production Engineer, Quality, Quality Engineer