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Senior scientific expert qa filling

Bern
CSL Plasma Inc.
Inserat online seit: Veröffentlicht vor 16 Std.
Beschreibung

PpProduct 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. /ph3Responsibilities /h3ulliUnder general supervision, maintain Quality Assurance System to ensure compliance with company and cGMP standards. /liliReview and approve GMP documentation, batch records, and release documentation to ensure compliance with internal and regulatory requirements. /liliManage deviations, investigations, and quality‑related decision‑making in collaboration with cross‑functional stakeholders. /liliSupport authority inspections and prepare responses to regulatory questions from agencies such as Swissmedic and FDA. /liliEnsure SOPs, quality systems, and GMP processes remain compliant with current regulatory expectations. /liliDeliver GMP training and promote quality awareness throughout the organization. /li /ulh3Qualifications /h3ulliMaster's degree in Pharmacy, Chemistry, Biology, Biotechnology, Engineering, or a related scientific discipline required. /liliAt least 3 years of GMP experience in Quality Assurance, aseptic manufacturing, filling operations, or a comparable regulated environment. /liliExperience supporting batch release, deviation management, inspections, and GMP compliance activities preferred. /liliStrong understanding of GMP requirements, Annex1, and aseptic manufacturing principles. /liliExperience interacting with regulatory authorities (FDA, EMA, Swissmedic) or supporting inspections is an advantage. /liliFluent German required; strong English communication skills a plus. /li /ulpDifferent qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable. /ppEqual Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit /p /p #J-18808-Ljbffr

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