What are the responsibilities and job description for the QA Microbiology SME position at TekOne IT Services Pvt. Ltd.?
Apply in-depth knowledge of microbiology, aseptic techniques, microbial control, and environmental monitoring (EM) for controlled environments.
Conduct microbiological testing, including bioburden and endotoxin assays.
Provide technical writing support for microbial control documents, including Standard Operating Procedures (SOPs), validation and qualification documents (IQ/OQ/PQ), study protocols, and investigation reports.
Lead cross-functional discussions to support project completion and ensure sterility assurance.
Utilize GMP computer systems for processing change controls, managing technical documents, and conducting data trending and metrics analysis.
Support the review of deviations, change controls, and Corrective and Preventive Actions (CAPAs), actively participating in investigations and problem resolution.
Assist in developing and delivering training materials related to microbial control for various departments.
Assess Contract Manufacturing Organization (CMO) deviations related to microbial control and review partner change notifications.
Occasionally travel domestically and internationally as required.
Qualifications
Minimum of 10-14 years of experience in the pharmaceutical or biotechnology industry.
Proven experience in aseptic formulation and drug product filling operations.
Project management experience, including facility start-up and new product introduction (NPI).
Familiarity with clean utility systems and monitoring processes for microbial control.
Knowledge of regulatory guidelines, including Annex 1 and FDA guidance for drug products.
Experience with quality risk management tools such as HACCP, LOPA, and FMEA.
Background in developing processes for sterile drug product manufacturing, including sterility sampling, redundant filtration (SURF), and isolator operating practices.
Strong understanding of aseptic qualification, aseptic process simulation, and cleanroom behaviors to support sterility control.
Skills
Excellent communication and interpersonal skills.
Strong analytical and problem-solving abilities.
Ability to lead cross-functional teams and initiatives.
Detail-oriented with a focus on quality and compliance.
Proficient in using GMP-compliant computer systems and data analysis tools.
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