Vendor Quality Support

il y a 3 semaines

Brainel'Alleud, Wallonie, Belgique Randstad Temps plein

We are looking for a Vendor Quality Support, for one of our clients based in Braine-l'Alleud/Wavre.

Don't hesitate to contact me : anne- - Life Sciences Wallonie.

This is a contract as a Consultant (employee or freelance).

responsabilités

As a Vendor Quality Specialist, here are the tasks:

Review annual stability protocol and reports. Communicate any trends to the Vendor Quality Lead (VQL). Perform review of CMO PQR within agreed timeframe, complete PQR Assessment and discuss outcome with VQL. Participate to Quality Agreements (QAA) periodic reviews and draft QAA according to available templates. Perform stakeholder review of various change controls, support change control preparation, keeping change control trackers up to date accordingly. Participate on ad-hoc basis to the Product Change Control Committees. In specific cases, review Validation and Technical Transfer protocols and reports liaising with VQL. Review Master Batch records changes linked to change controls or to support initiation and review batch records to support batch release. Investigations/deviations/ out-of-specifications. Perform the QA review of deviation notifications, retrieve and collect supportive information from involved stakeholders to allow and perform assessment. Log and follow up on the relevant system. If needed work with the Vendor Quality Lead, the Vendor team and Global Quality Lead to determine the Root cause of issues which may lead to a Technical meeting. Coordinate vendor quality related investigations. Log and follow up on the relevant system. Support Inspections and Audits preparation at the company or at the vendors, when relevant act as SPOC and follow-up CAPAs in the relevant system. Support Risk based evaluation of the vendors in collaboration with VQLs. Provide expert QA advice, support and management for technical operational QA and general QA matters associated with the assigned products and activities at the vendors. This can include participation to various QA improvement projects.Address CMO Connectivity Fail messages and coordinate resolution of issues internally and with appropriate vendors. Ensure regular update of relevant guidance. Act as substitute for other Quality Vendor Support/Quality Backoffice Coordinator in times of absenteeism (e.g. Vacation, illness, etc.) Quality ComplaintsLiaise with CMOs to handle requests from RA and Partners.
qualifications As a Vendor Quality Support, here are the requirements: Fluent and confident use of English language verbally and in reading & writing Must be knowledgeable in several areas of the global pharmaceutical industry, including the interpretation and practical application of applicable regulations. Has good background knowledge of the pharmaceutical industry from a business and technical perspective. Ability to work autonomously for the assigned activities with limited supervision Must be able to act in most circumstances without direct supervision and handle complex/difficult situations. Output from actions will most likely impact activities across several departments. Must be able to effectively interact with and influence senior internal and external personnel on many aspects of project and product related matters. Must possess excellent interpersonal, verbal and written communication skills at all levels internally and externally especially at senior management levels. Generate commitment from within teams, encourage and support new ideas and act as a role model for others in driving the projects and the company vision. Must be skilled and experienced in operating across cultures and in a multi-cultural environment. Knowledgeable and experienced in root cause analysis and risk management/assessment skills. Must have the ability to independently analyze data and information to draw conclusions and make effective decisions. Must be able to develop innovative solutions through judgment and reasoning leveraged from extensive quality experience
qu'offrons-nous For this position of Vendor Quality Support, we offer an attractive salary with the following benefits Group & hospitalisation insurance 7 euros meal voucher per working day Reimbursement km or company car Monthly allowance (80 euros net per month) A 13th month Training A rate as a freelancer is also possible.

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