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**Asset Excellence Manager (M/F/d) - Microbiological Department / Quality Assurance and Control / MES, Laboratory and Quality Management Systems / GMP / Batch Record Review / Deviations / German / English**
**Project / Role**:
For our client, a large pharmaceutical company based in Basel, we are looking for an Asset Excellence Manager (M/F/d).
**Background**:
The Asset Excellence Manager in the Antibiotics 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 production possible is another priority, 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 responsibility and the associated responsibilities are determined in consultation with the supervisor.
**Tasks & Responsibilities**:
- Process activities & production processes: Optimization, testing, validation & qualification of systems and products, contact person for processes & systems, participation in launches, transfer projects & process validations, definition of production & process processes, process monitoring & support with compliance issues.
- Batch Record Review & Posting Control: Checking the completeness and accuracy of batch records, forwarding documentation to QA and batch closing, comparing balanced quantities with SAP data, corrective postings and warehouse inventory postings
- MES Activities & Documentation Management (PQS): Creating and testing recipes and manufacturing instructions, coordinating and approving master batch records, creating and maintaining GMP documents, ensuring current PQS processes
- Deviation and Change Management (Deviations, Complaints, CAPAs, Changes): Processing events, deviations and complaints as owner or SME, conducting root cause analysis (RCA) and trend analyses, processing changes as change owner
- Hygiene and zone concepts: Implementation and compliance with the hygiene, cleaning and zone concept in the responsible building/area. Handling deviations from the required hygiene requirements
- Inspection management: Representing the department as an SME during inspections and audits, preparing, coordinating and supporting inspections/audits (internal and external), coordinating the follow-up of measures and completing them on time
- Quality Risk Management (QRM): Responsibility for the QRM process within the scope, planning, creating and moderating risk analyses, supporting as an SME
- Training and courses: Creating training courses and training concepts, organizing and conducting training courses, managing training profiles, taking on tasks as a “training partner”
- Project management: Leading, coordinating, supporting and collaborating on local and global projects
- KPI, LPS and standardization: Regular review of key performance indicators and deriving improvements, using LPS tools, supporting problem solving, alignment and harmonization between teams, participating in relevant planning and control meetings
- Safety and environmental protection: Ensuring compliance with safety and environmental regulations, promoting operational safety and implementing 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 and control or a related industry is an advantage
- Experience in a GMP-regulated environment including processing deviations
- Experience in batch record review
- Very good communication skills, both written and spoken in German
- 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, laboratory and quality management systems
**Nice to haves**:
- English skills
**Reference no.: 924202SDA**
**Role** : Asset Excellence Manager (M/F/d)
**Industry** : Pharma
**Location** : Kaise
