Major responsibilities

• Perform microbiological testing-related work, including pharmaceutical microbial limits testing, sterility testing, bacterial endotoxin testing, cleaning validation, cleanroom environmental monitoring, and strain bank/library testing.
• Participate in developing microbiological quality standards and standard operating procedures (SOPs) for analytical methods related to material control.
• Participate in developing microbiological quality standards and SOPs for analytical methods related to in-process control, intermediates, and finished products.
• Propose or participate in analytical method optimization; participate in drafting method qualification/verification and method transfer protocols; issue method qualification and method transfer reports.
• Participate in developing stability study protocols for intermediates and finished products; organize personnel to conduct stability study experiments and review stability data.
• Organize training for microbiology testing technicians, including pre-job/onboarding training for new employees and on-the-job training/retraining for existing employees (e.g., GMP regulations, professional technical knowledge, microbiology testing-related SOPs, etc.).
• Participate in formulating GMP-compliant area management procedures and workflows for the microbiology laboratory and ensure normal operation of the laboratory areas.
• Organize personnel, as planned, to perform sample aliquoting for raw materials, excipients, packaging materials, in-process products, intermediates, finished products, and stability samples; manage samples under testing.
• Organize personnel, as planned, to perform testing; complete testing records, review testing results, issue test reports, and promptly report to upper management.
• Organize personnel, as planned, to conduct cleanroom environmental monitoring; promptly capture environmental isolates, perform isolation, identification, and library creation; compile environmental monitoring data, issue environmental monitoring reports, and promptly report to upper management; organize personnel to participate in cleanroom environmental qualification/validation.
• Organize personnel, as planned, to perform data collection, statistics, and trend analysis for process gases and cleanroom environmental monitoring; support completion of product (annual) quality reviews.
• Where microbiology-related outsourced testing is required, participate in supplier audits, execute contracts, arrange personnel for sample submission, collect outsourced test reports in a timely manner, and perform review/sign-off.
• Procure microbiology testing-related reagents, consumables, reference standards, and microbial/toxin strains as planned, ensure normal testing needs are met, and store/manage them per requirements.
• Organize personnel to perform horseshoe crab reagent (LAL) sensitivity requalification for new lots, suitability testing for culture media, and manage prepared test solutions per relevant requirements.
• Organize personnel to manage the testing strain bank/library.
• Organize personnel, as planned, to carry out sterilization validation and cleaning validation.
• For abnormalities identified during testing or outsourced testing, promptly report to upper management and organize OOS/deviation investigations; if confirmed as not attributable to, or with no traceable root cause within, the laboratory, assist in investigating other potential causes.
• Ensure proper operation of microbiology-related instruments and equipment; arrange regular maintenance and calibration; promptly report malfunctions for repair.
• Cooperate with internal and external audits and complete required corrective actions within planned timelines.
• Complete other laboratory-related tasks assigned by management on schedule.

Education, Qualifications, Skills and Experience

• Education: Bachelor’s degree or above in microbiology or related disciplines.
• Experience: Minimum three years of experience in pharmaceutical testing or pharmaceutical quality-related work.
• Regulations and Standards: Familiar with GMP regulatory guidelines and major pharmacopeias of various countries; familiar with quality management systems.
• Laboratory Practices: Proficient in pharmaceutical microbiology laboratory practices, including microbial limits testing, sterility testing, bacterial endotoxin testing, cleaning validation, environmental monitoring in cleanrooms, strain bank/library testing, and related techniques.
• Digital Skills: Proficient in computer use and Microsoft software.
• Soft Skills: Strong communication, presentation, organization, and coordination skills, with good English proficiency in listening, speaking, reading, and writing.