Microbiogy Specialist

Sandoz; Gebze; On-site; TRY 30,000 - 50,000; Full time

Job summary

A leading pharmaceutical company in Gebze is seeking an experienced microbiologist to conduct microbiological analyses and ensure compliance with quality standards. The ideal candidate will have a Bachelor’s degree in a relevant field and at least 4 years of experience in a laboratory setting. Responsibilities include preparing procedures, conducting audits, and evaluating microbiological controls, all within a GMP environment. Strong communication skills and attention to detail are essential.

Qualifications

• 4+ years of experience in a microbiology laboratory, preferably in the pharmaceutical industry.
• Good command of English (reading, writing, speaking).
• Knowledge of GMP practices and quality control processes.

Responsibilities

• Prepare and track revisions of laboratory procedures in compliance with regulations.
• Conduct microbiological analyses of various products and materials.
• Implement and evaluate environmental monitoring programs.
• Prepare for audits and conduct risk assessments.

Skills

Microbiological analysis techniques

Problem-solving skills

Decision making skills

Quality Control Testing

Communication skills

Attention to detail

Education

Bachelor’s degree in Microbiology, Biology, Molecular Biology & Genetics, or Bioengineering

Tools

MS Office programs

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.