Senior Quality Systems Manager - Life Sciences
ALTEN Group is a leader in outsourced Engineering and IT Enterprise Services.
In the last 30 years, ALTEN has grown into a company composed of 54,000 employees (88% engineers) working with prestigious companies across various industries.
ALTEN Switzerland has been a reference partner since 2005, offering Engineering services to 100 world leading companies. Our activities cover all main areas of the Swiss market in Life Sciences, Engineering & IT Services.
Key Responsibilities:
* Ensure compliance with ISO/cGMP quality system requirements, including knowledge of PICS Guide to Good Manufacturing Practices Part 1 and 2 or EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1.
* Provide immediate support to operations and quality control staff addressing compliance related concerns.
* Making independent quality-related decisions based on regulatory and compliance knowledge and providing independent quality support to project teams.
* Audit internal quality system elements in manufacturing and operational support areas.
* Oversee compliance of Change Controls, CA/PA and investigations, OOS and deviations. Perform external audits of suppliers/vendors/off-site facilities.
* Act as a customer interface during on-site audits, conference calls and other standard means of communication.
* Prioritize and manage multiple projects simultaneously.
* Review and approve validation documents.
* Review Master Batch Records (MBR) and supporting documents. Release batch records as needed.
Key Requirements:
* Direct QA commercial drug substance/drug product experience required or equivalent aseptic processing and cell therapy manufacturing experience.
* GMP compliance and Part 11 compliance knowledge preferred.
* Experience with oversight of aseptic processing and associated international regulations.
* Excellent written and oral communication skills, including accurate documentation abilities, fast-paced environment adaptability, team-oriented work ethic and strong independence.
* Able to interface directly with clients.
* Proficient in Microsoft Office and database management, organizational, record-keeping and multi-project handling skills.
* 5-10 Years Experience.
We offer permanent contracts and flexibility to work with multiple prestigious clients. Our global presence provides access to national and international business opportunities in an innovative market always up-to-date with the latest technologies.
We provide sought-after trainings and workshops ranging from hard to soft skills, awarding certificates that increase qualifications and enable participation in groundbreaking projects.
This position requires direct interaction with clients, ensuring seamless communication and exceptional results.
Seniority Level
Mid-Senior level
Employment Type
Full-time
Job Function
Science and Quality Assurance
Industries
Pharmaceutical Manufacturing and Engineering Services