Responsibility for microbial testing relate work (contain sterile testing, bioburden testing and EM)

Major accountabilities:

Operational

•OOx/deviation handling

•CAPA definition

•KPI trending

•Ensure all activities in compliance with cGxP, incl. data integrity

•Review and approval of analytical data / tests (analytical release)

•Perform microbiological testing of materials and utilities, environmental and personnel monitoring

•Provide expert support for site qualification and validation activities

•Maintain and calibrate equipment incl. plan preparation

•Support in supplier qualification

•Trending and analysis of KPI/KQI of environmental monitor data.

•Support sample planning and sampling execution

HSE

•Comply with all HSE guidelines

•Detect and report potential accident, risks and propose solutions

•Participate in HSE risk assessments

•Preparation and participation to internal HSE audits

•Responsible for participating in initial training and retraining

Key Performance Indicators

•Analytical lead times

•Timely and GMP-compliant analysis and documentation of the results

•Error rate: Number of OOS (analysis errors) related to the number of analyzes

•No complaints about official inspections

Ideal Background

Relevant Experience

•Professional experience (3-5 years) in the pharmaceutical sector or in the manufacture of active substances in analytical laboratories in a GMP environment or equivalent

Collaborating across boundaries

Functional Breadth

efficient inter and intra-departmental communications.

Education & Qualification

•Technical education & 3-5 years relevant experience or

•University degree in Microbiology, Biochemistry or equivalent + 0-4 years working experience

Languages

Good (oral and written) in English

fluent in local language (oral and written)

Competencies

•Collaboration

result-oriented

•Breakthrough Analysis

Being Resilient

Operational Excellence

Continuous Learning

Digital & Tech Savvy

•MS Office applications and other standard IT applications supporting Quality activities

•Laboratory equipment

Quality Control (QC) Testing

Quality Control Sampling

Knowledge of TQM and related industry GxP standards and processes

Laboratory Excellence

Quality decision making

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Quality Control (Qc) Testing

Industry Standards

Decision Making Skills

Laboratory Excellence

Continued Learning

Laboratory Equipment

Dealing With Ambiguity

Total Quality Management

Technological Expertise

Self-Awareness

Gxp

Quality Control Sampling