Quality and Documentation Manager
Vor 2 Tagen
With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the leading company solely dedicated to skin and advancing the future of dermatology.
We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients and the healthcare professionals we serve every day. We aim to empower each employee and to promote their personal growth all the while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy and personal rights of every employee.
At Galderma, we actively give our teams reasons to believe in our ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create unparalleled, direct impact.
**Job Description**:
With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the leading company solely dedicated to skin and advancing the future of dermatology.
We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth all the while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.
At Galderma, we actively give our teams reasons to believe in our ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.
We are currently looking for our New Quality and documentation Specialist to join our team. The role is based in our Lausanne, Swiss site.
The Quality and Documentation Specialist role is part of the Product Development Quality team. Reporting to the global Head of Product Development Quality, the incumbent will be responsible for maintaining all internal and external data records that support or will be included in Quality Management system. The jobholder will prepare internal SOPs, have oversite and coordination vendor audits to confirm data integrity, GMP, protocol and SOP compliance. The individual is responsible for creating and maintaining a KPI data management to measure the quality management system.
As the Global Product Development Quality Specialist, you will ensure that Galderma products meet the company quality standards and comply with the relevant government regulations according to the product applicable classification: GMP, GDP, ISO, ICH or any relevant regulations and guidance with a focus on biotechnology products and combination products.
Roles and Responsibilities:
Product Development Projects:
- Management of documentation being provided from multiple disciplines including any requests, approvals, changes and signoffs related to provided documentation including the design documentation for a new biotechnology product- Preview and approval of documentation needed for the submission to notified body and health authorities in quality assurance- Ensure all documentation related to product development are done properly according to GDP’s and maintained in Galderma Document Management System- Initiate, assess and handle Change Controls in Galderma QMS and work with all stakeholders for timely implementation of the changes- Prepare documentation and quality oversight for health authority inspection and internal audits.- Responsible for internal SOP generation and Quality database maintenance and compliance; has oversight of, or directly performs quality review of, all documentation supporting a holistic view on the Quality Management System- Participate in product innovation projects in Product Development Quality- Actively participate and represent Quality in the appropriate product development team meetings- Responsible to ensure adherence to the relevant applicable regulatory GMP requirements as well as Galderma’s internal requirements throughout all the processes in product development projects- Responsible to initiate, perform and document quality investigations, deviations and CAPA’s related to product development in Galderma QMS- Evaluate the robustness of the QMS and weigh in on quality risks- Participate in internal and external audits related to product development- Drive the vendor qualification program and work closely with all stakeholders to ensure all suppliers and vendors involved in the development are properly qualified according to Galderma procedures and requirem
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