Product quality and patient safety are at the heart of everything we do. As part of the Quality Assurance division within the Filling department, you will ensure compliance with GMP requirements, support product release activities, and contribute to the continuous improvement of aseptic manufacturing processes. In this role, you will serve as a key partner to Manufacturing, Quality functions, and regulatory authorities in a fast‑paced and highly regulated environment.
Responsibilities
* Under general supervision, maintain Quality Assurance System to ensure compliance with company and cGMP standards.
* Review and approve GMP documentation, batch records, and release documentation to ensure compliance with internal and regulatory requirements.
* Manage deviations, investigations, and quality‑related decision‑making in collaboration with cross‑functional stakeholders.
* Support authority inspections and prepare responses to regulatory questions from agencies such as Swissmedic and FDA.
* Ensure SOPs, quality systems, and GMP processes remain compliant with current regulatory expectations.
* Deliver GMP training and promote quality awareness throughout the organization.
Qualifications
* Master's degree in Pharmacy, Chemistry, Biology, Biotechnology, Engineering, or a related scientific discipline required.
* At least 3 years of GMP experience in Quality Assurance, aseptic manufacturing, filling operations, or a comparable regulated environment.
* Experience supporting batch release, deviation management, inspections, and GMP compliance activities preferred.
* Strong understanding of GMP requirements, Annex 1, and aseptic manufacturing principles.
* Experience interacting with regulatory authorities (FDA, EMA, Swissmedic) or supporting inspections is an advantage.
* Fluent German required; strong English communication skills a plus.
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
Benefits
For more information on CSL benefits, visit How CSL Supports Your Well‑being | CSL.
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
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