Asset Excellence Manager (m/f/d) – GMP / pharmaceutical production / quality assurance / deviations / batch record review / MES, quality management systems / German / shift work
Project / Role:
For our client, a large pharmaceutical company based in Basel, we are looking for a qualified
Asset Excellence Manager (m/f/d).
Background :
The Asset Excellence Manager in the Sterile Filling Visual Inspection Manufacturing Unit is responsible for coordinating compliance activities related to the facilities, processes, and manufactured products in his area. In addition to GMP compliance, ensuring the most trouble-free and stable inspection possible is another key focus, which is achieved through independent and continuous improvements.
It is the responsibility of the position holder to ensure that production facilities and building structures are GMP-compliant, in accordance with current national and international GMP regulations as well as Roche's internal requirements. This requires in-depth knowledge of operational processes and facilities, as well as excellent organizational skills for project management.
The position holder serves as the contact person within and outside the department regarding the initiation, coordination, and implementation of all necessary measures to achieve and maintain GMP compliance. They are responsible for ensuring compliance with GMP regulations within the department. To this end, the position holder has the authority to issue technical instructions regarding GMP matters to
all personnel in the department and the support functions. The focus of the position and the associated responsibilities are determined in consultation with the supervisor.
The ideal candidate will have a degree in pharmaceutical, scientific, or technical fields and more than two years of professional experience. Experience in a GMP-regulated environment, including the processing of deviations, as well as professional experience in pharmaceutical production are also essential. Excellent communication skills in German and English round out the profile, complemented by experience with MES and quality management systems.
Tasks & Responsibilities:
* Process activities & production processes: Optimization, testing, contact person for processes & systems, participation in launches, transfer projects & process validations, definition of production & process processes
* Batch Record Review: Checking for completeness & accuracy of batch records, forwarding documentation to QA & batch completion
* MES activities & documentation management (PQS): Creation & testing of recipes & manufacturing instructions, coordination & approval of master batch records, creation & maintenance of GMP documents, ensuring current PQS processes
* Deviation & change management (deviations, complaints, CAPAs, changes): Processing of events, deviations & complaints as owner or SME, conducting root cause analysis (RCA) & trend analyses, processing of changes and CAPAs as change/CAPA owner
* Inspection management: Representing the department as SME during inspections & audits, preparation, coordination & support of inspections/audits (internal & external), coordination of Monitoring of measures and timely processing
* Quality Risk Management (QRM): Responsibility for the QRM process within the scope, support as SME (approver)
* Training & courses: Creation of training courses & training concepts, organization & implementation of training courses, management of training profiles, assumption of tasks as a "training partner"
* Project management: Management, coordination, support & collaboration in local and global projects
* KPI, LPS & standardization: Regular review of key performance indicators & derivation of improvements, application of LPS tools, support of problem solving, alignment & harmonization between teams, participation in relevant planning & control meetings
* Safety & environmental protection: Ensuring compliance with safety & environmental regulations, promoting operational safety & implementation of accident prevention measures
Must Haves:
* Completed pharmaceutical, scientific or technical studies or vocational training in combination with at least 2 years of professional experience
* Professional experience preferably in the microbiological field, in pharmaceutical production, development, quality assurance or control
* Experience in a GMP-regulated environment including processing deviations
* Experience in batch record review
* Very good communication skills, both written and spoken, in German and English
* High level of commitment to the position and the employer, openness to new ideas, resilience and flexibility as well as consistent performance despite changing requirements
* Experience with MES, quality management systems
Reference no.: 924318SDA
Role : Asset Excellence Manager (m/f/d)
Industry : Pharma
Location : Kaiseraugst
Working hours : 100% (Home Office: yes, max. 20%)
Start : ASAP (latest possible start date: September 15, 2025)
Duration : 24+
Application deadline : July 24, 2025
Job Type: 100%
Work Location: On the road
