Vendor Quality Support

Contenido de trabajo

Vendor Quality Support- 9098

Work location

Braine-l’Alleud

Introduction

In this transversal matrix role you will provide Quality expertise and support to a group of Vendor Quality Lead professionals who manage and oversee operational quality management of externalized manufacturing activities for intermediates, APIs, bulk and finished drug products.

interested ?

please take a look at the description below and feel free to contact me,

julie.licoppe@professionals.randstad.be

Organisation/Department

Our client is a global biopharmaceutical company focusing on creating value for people living with neurology and immunology conditions

Job description

your main tasks will be :

Support to Vendor Quality Leads

• 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.
• 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.
• 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.
• Support Audits preparation, when relevant act as SPOC in case of audits and follow-up CAPAs in Trackwise.
• 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.)
• Work in accordance with our client HSE and Corporate policy requirements and drive personal training and development activities to meet the needs of the business and professional career development
• Quality Complaints: Perform trend, recurrence analysis with the Central Complaint Unit, escalating issues to VQL. Be a contact person for the follow-up with vendors for the manufacturing investigation part.

Requirements

• 5-10 years professional experience & knowledge in a Quality role in the pharmaceutical industry preferably in the GMP operations environment
• Knowledge with pharmaceutical formulations (e.g., tablets, capsules, oral solutions, injectables, transdermal systems)
• In-depth knowledge with the manufacture / testing of pharmaceutical formulations (e.g., tablets, capsules, oral solutions, injectables, transdermal systems)
• Hands-on field experience in failure investigations, root cause analysis, deviation review
• Solid knowledge about European Good Manufacturing Practices (Eudralex Vol. 4)
• Fluent in English

preferred soft skills :

• 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.

Offer

Consulting

We offer an attractive salary with extra-legal advantages :

• Group insurance
• Hospitalisation insurance
• Meal vouchers of 7 euros gross per working day
• Reimbursement km or company car
• Monthly allowance (80 euros net per month)
• A 13th month
• Training
• Etc