QC Microbiology Specialist

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.