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Microbiogy Specialist
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Job Description
Major accountabilities:
Work Experience:
Major accountabilities:
- 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) Stability -Stability testing (Projects) – protocol preparation, evaluation, report preparation.
- Reporting (Stability plan preparation, trend analysis, evaluation)
- Performance of Stability studies, protocols and comparative reports for supplier qualification -Review and approval of analytical tests (analytical release)
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Microbiological QC -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 -Support sample planning and sampling execution -Reporting of technical complaints / adverse events / special case scenarios related to Sandoz products within 24 hours of receipt -Distribution of marketing samples (where applicable)
- To prepare, update, and track revisions of laboratory procedures in accordance with current and legal regulatory guidelines.
- To work in compliance with current GMP rules and company procedures.
- To conduct and report necessary activities within the quality management system (OOS/OOT, Deviation Investigation, Change Control, and Corrective and Preventive Actions).
- To perform and report microbiological analyses of raw materials, semi-finished products, finished products, and packaging materials.
- To carry out and report the microbiological method validation and verification studies.
- To implement the environmental monitoring program, evaluate results, and report findings.
- To perform and evaluate the microbiological controls of compressed air systems.
- To perform and evaluate microbiological analyses of the water system.
- To perform microbiological analyses of detergents and disinfectants used.
- To perform, evaluate, and report disinfectant efficacy studies in accordance with pharmacopeia and related standards.
- To prepare all culture media and solutions used in the laboratory according to instructions and to perform growth promotion studies.
- To prepare for and participate in customer and regulatory audits.
- To conduct and report Microbiological Risk Assessments and OPEX studies.
- To perform bulk holding time (BHT) studies, evaluate results, and report findings.
- To ensure the calibration and verification of used equipment are carried out and tracked.
- To support the qualification and calibration processes of laboratory equipment.
- To ensure the regular and effective operation of the microbiology laboratory.
- To ensure the preparation of periodic trend reports and their timely implementation.
- To ensure that laboratory records are accurate and complete.
- To track, prepare, and report reference cultures of microorganisms.
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To perform and report microorganism identifications.
- The relevant KPIs that are defined in the Quality Control areas apply: e.g. analytical lead times -Timely and GMP-compliant analysis & documentation of the results.
- Error rate: Number of OOS (analysis errors) related to the number of analyzes -No complaints about official inspections.
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Individual performance is assessed using the PMP performance dialog together with the manager
Work Experience:
- Functional Breadth.
- Preferably at least 4 years of experience in a microbiology laboratory, particularly in the pharmaceutical industry (especially in non-sterile manufacturing).
- Collaborating across boundaries.
- A GMP environment/equivalent.
- Bachelor’s degree in Microbiology, Biology, Molecular Biology & Genetics, or Bioengineering from the university.
- Good command of English (reading, writing, speaking).
- Knowledge and experience in microbiological analysis techniques (e.g., disinfectant efficacy studies, non-sterile product analysis tests, etc.).
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Proficiency in MS Office programs.
- Continuous Learning.
- Dealing With Ambiguity.
- Decision Making Skills.
- Gxp.
- Industry Standards.
- Laboratory Equipment.
- Laboratory Excellence.
- Quality Control (QC) Testing.
- Quality Control Sampling.
- Self-Awareness.
- Technological Expertise.
- Total Quality Management.
- Team-oriented, with strong communication skills, responsible, and detail-oriented.
- Possesses problem-solving and analytical thinking skills.
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Able to keep up with the busy work tempo
- English.
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