Bioanalysis Specialist

Job Title:

Bioanalysis Specialist

This is a specialized position in bioanalysis that requires a deep understanding of microbiology and its applications in the API/Pharmaceutical industry.

The successful candidate will have a degree in Microbiology, Biotechnology or any Life sciences domain and 2-4 years of experience in the API/Pharmaceutical industry.

This role involves performing environmental monitoring of classified areas to ensure aseptic conditions, sampling and testing of purified water and raw water, and conducting microbiological validation studies.

The specialist will also participate in qualification of controlled areas, equipment, and utilities, prepare and review Standard Operating Procedures (SOPs), protocols, and reports, and maintain accurate microbiological records as per GMP and data integrity requirements.

• Perform environmental monitoring of classified areas (air, surfaces, and personnel) to ensure aseptic conditions.
• Sampling and testing of purified water and raw water.
• Conduct microbiological validation studies (e.g., filter integrity testing, media fills for aseptic processes).
• Participate in qualification of controlled areas, equipment, and utilities (HVAC, water systems, compressed air).
• Prepare and review Standard Operating Procedures (SOPs), protocols, and reports.
• Maintain accurate microbiological records as per GMP and data integrity requirements (ALCOA+ principles).
• Support regulatory inspections and customer audits and respond to microbiology-related queries.
• Participate in out-of-specification (OOS) or out-of-trend (OOT) investigations related to microbial results.
• Perform root cause analysis and propose corrective and preventive actions (CAPA).
• Conduct microbiological risk assessments of processes and systems.
• Maintain microbial culture collection and reference strains.
• Ensure calibration and qualification of lab instruments (incubators, autoclaves, laminar airflows, microscopes).
• Ensure proper handling, disposal, and biosafety practices for microbial cultures.
• Train production and quality staff on microbiological hygiene and aseptic practices.
• Contribute to continuous improvement of contamination control strategies.
• Stay updated with pharmacopeia changes, ICH guidelines, and regulatory expectations.

• Bachelor's or Master's degree in Microbiology, Biotechnology or any Life sciences domain.
• 2-4 years of experience in the API/Pharmaceutical industry.

• A competitive salary package.
• Ongoing training and development opportunities.
• A dynamic and supportive work environment.