GxP Compliance Specialist – Quality Control
Overview
ALTEN Group
Within 30 years, ALTEN has become leader in both outsourced Engineering and IT Enterprise Services. ALTEN, composed of 58,000 employees (88% engineers), carries out complex and highly technical projects throughout the value chain of 6,500 clients, the most prestigious companies in all sectors of industry, services and telecommunications. We work with key actors in the Aeronautics & Space, Defense & Naval, Security, Automotive, Rail, Energy, Life Sciences, Finance, Retail, Telecommunications and Services sectors.
Since 2005, with 450 current employees, ALTEN Switzerland is a reference partner in providing Engineering services to 100 world leading companies. ALTEN Switzerland’s activities cover all the main strategical areas of the Swiss market in Life Sciences, Engineering & IT Services.
Key Accountabilities
Support the QC team in their daily operations as an expert of compliance aspects for QC.
Manage, investigate and close events and deviations in support of Subject Matter Experts in QC.
Contribute to the data review process according to the established quality requirements.
Manage and support the timely and effective completion of deviations, non-conformances, investigations, change controls, and CAPAs; perform period reviews.
Continuously improve data integrity (DI) knowledge base, including DI riskanalysis assessments and action plans, and periodically report status/progress to leadership team.
Author, review, approve and maintain life cycle of relevant Standard Operating Procedures, Work Instructions, and all other quality documents related to areas of responsibility, as well as support other areas as required.
Contribute to the assessment of regulatory and pharmacopoeia updates linked to QC activities.
Support preparation of audits and interact directly with internal HCQ auditors and external regulatory agencies.
Recommend and drive improvements to existing systems, processes, techniques or programs.
Manage training plans of the team and support in ensuring training compliance.
Collaborate with cross-functional teams, in particular act as Single Point of Contact to QA, to address compliance issues and implement corrective actions.
Provide training and guidance to staff on GxP regulations and best practices.
Stay updated on industry regulations and trends to ensure continuous compliance.
Work Experience
Practical experience working in a QC lab.
Experience with Quality Systems such as Deviation, CAPA, Change control.
Strong knowledge of GLP/GMP/Quality System requirements and international guidelines (e.g. ICH, FDA, EMA) for biopharmaceuticals; knowledge of Data generation, Data processing, Data Quality principles.
Excellent investigational and problem-solving skills. Ability to interpret complex situations and to articulate recommendations for issue resolution.
Previous direct experience in audits and interactions with health authorities.
Preferred hands-on experience with laboratory information systems, digital tools, automation technologies and lean principles.
Soft Skills
Highly motivated, self-driven, autonomous, flexible and able to multi-task to support department and business objectives.
Proactive in delivering results and driving improvements
Strong communication and interpersonal skills, with the ability to work effectively in a team environment.
You are fluent in English (B2 or higher), French is a plus.
Seniority level
Associate
Employment type
Full-time
Job function
Quality Assurance
Industries
Engineering Services and Pharmaceutical Manufacturing
What we offer you
At ALTEN, we offer you the security of a permanent contract while also giving you the liberty to work with multiple prestigious clients. With the luxury of having a wide range of offices around the world, we are in a unique position to provide you with the freedom to experience national and international business opportunities. Thus, we function in a highly innovative market, always being up to date with the latest technologies and making you a pioneer in your field.
Therefore, we offer our employees sought-after trainings and workshops ranging from hard to soft skills and providing you with certificates that will further increase your qualifications, enabling you to participate in ground-breaking projects.
Apply now and be a part of our amazing journey. We believe in growing together!
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