QC Microbiology Specialist

Job Description Summary

This role ensures product and process microbiological integrity and regulatory compliance through comprehensive laboratory testing, quality system management, method validations, disinfectant efficacy studies and environmental monitoring.

Job Description

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)

• 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)

 

Job Description: 

• 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.

·       To perform and report microorganism identifications.

Key performance indicators:

• 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.

• Individual performance is assessed using the PMP performance dialog together with the manager  

Minimum Requirements: 
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.).

• Proficiency in MS Office programs.

Skills:

• 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.

• Able to keep up with the busy work tempo

Languages:

• English.

Skills Desired

Continued 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