vendor quality lead & qp - 13810.

As Vendor Quality Lead & QP , your main tasks and responsibilities will be :

• Be the central QA point of contact for the organization for investigations / deviations / out-of-specifications / audit observations associated with the assigned vendors. Perform the
• QA review of deviation notifications, retrieve and collect supportive information from involved stakeholders (Vendor Team, CMC Lead, Industrial Leads, Business) to allow assessment.
• Manage the key performance indicators (metrics) for key operational QA activities and services associated with the vendors in the defined described tracking tools and track the
• vendor’s performance : Ensure all Quality agreements are in place and take ownership of agreements for the vendors. Maintain Quality Agreement with the vendors up to date and perform periodicreviews and update of the agreement in close collaboration with the vendors.
• When applicable, be sure that the Annual Product Stability Program is rolled-out andexecuted at the vendor in accordance with the Stability Program
• Ensure the Product Quality Reviews (PQR) are completed by the vendors in a timely manner and as needed and are reviewed within the requested time period. Ensure that this review is documented and made available in Controlled Documents System
• Participate as QA representative to the recurrent vendor meetings, present issues and re solutions, and drive vendor quality performance through these meetings
• Quality Complaints: be the contact person for the follow-up with vendors for the manufacturing investigation part. When applicable, ensure that initial receipt, logging of
• quality complaints into the Complaint System and provision of responses to the
• complainant are professionally coordinated and managed.
• If needed work with the Vendor team and CMC Lead to determine the Root cause of issues which may lead to a Corporate Technical Review (CTR) escalation meeting. Coordinatevendor quality related investigations
• Participate on ad-hoc basis to the Product Change Control Committees for activities related to the vendors
• Provide expert QA advice, support and management for technical operational QA and general QA matters associated with the vendors
• Work closely with Corporate QA teams, Technical Operation Teams, Business stakeholders and Affiliates in an effective and efficient way
• Cover the entire product life cycle from initial commercialisation including TechnologyTransfer/Knowledge transfer, commercial (key raw materials to distribution), productimprovements to phase out for the assigned vendors

For the QP part of the role, here are your main accountabilities:

• Support the QP in relation to all batch release activity, primarily performing QA review of batch documents.
• Issue batch certificates for product release and distribution
• Perform in SAP the transactional product release and maintenance of batch release register
• Liaise with Vendor Team(s) and CMO’s where applicable on resolution of issues relating to document errors to support release.
• Act as QA contact (in conjunction with site QP) and deputize on behalf of QP where appropriate for product related quality issues and associated communications.
• Act as a contact with other departments and Affiliates to support the drug product /Finished goods release process and supply of post release documents.
• Maintain and report Metrics relating to batch release activities.
• Support Global Regulatory Affairs and CMC Quality Leads for submission document requests
• Coordinate legalization/notarization of documents as needed

As Vendor Quality Lead & QP, we expect the following competencies and skills 

Education & Qualification:

• Master's Degree
• Languages: French and English, fluent
• Registration (Describe): Eligibility as a Qualified Person
• in EU Competences
• Industrial Pharmacist having the registration number for Qualified person.
• Experience of min 5 years is expected in aseptic manufacturing process and release activities
Must be knowledgeable in several areas of the global pharmaceutical industry, including the interpretation and practical application of applicable regulations. Has good knowledge of the pharmaceutical industry from a business and technical perspective.

• 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.
• Possess good auditing capabilities and skills.
• Must be able to effectively interact with and influence senior internal and external personnel on many aspects of project and product related matters.
• Must have the ability to manage projects / activities across global geographies within the area of expertise. Be capable of leading and motivating teams and demonstrate professional maturity in difficult situations. Set challenging objectives for self and others and drive for results.
• 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 departmental / company vision.
• Be able to coach / train / mentor colleagues and deliver training within area of expertise and assist with the development of top talent.
• Must be skilled and experienced in operating across cultures and in a multi-cultural environment
• Root cause and risk management/assessment skills
• Problem solving (Describe the level of “self-starting” thinking required in the for recognizing, analyzing and solving problems)
• Must have the ability to independently analyze data and information to draw conclusions and make effective decisions.
• Must have ability to identify risks and propose corrective actions within areas of expertise. Also demonstrates initiative and the ability to help others solve problems in a creative and practical way
• Must be able to coach staff and colleagues through effective problem solving to ensure the best resolution is obtained.
• Must be able to develop innovative solutions through judgment and reasoning leveraged from extensive quality experience.