Microbiology - AM/DM

Aspiro Pharma Ltd.; Hyderabad; Sur place; INR 1 800 000 - 2 400 000; Plein temps

Résumé du poste

Aspiro Pharma Ltd. in Hyderabad, India seeks an experienced microbiologist to lead sterile injectable microbiology operations. This role covers testing, environmental monitoring, specialized assays, and investigations within a USFDA/EU-regulated facility.

Supervisory responsibilities include guidance to junior analysts and participation in CAPA and change controls. Required is an M.Sc. in Microbiology or related field with 8–15 years’ hands-on experience in sterile injectables, familiarity with

Qualifications

• M.Sc. in Microbiology, Biotechnology or Life Sciences is required; pharma background preferred.
• Experience: 8–15 years in sterile injectable microbiology within regulated facilities; supervisory experience advantageous.
• Knowledge of cGMP, GLP, WHO, USFDA, EU GMP and data integrity standards is essential.

Responsabilités

• Testing & Monitoring of raw materials, PW, WFI, gases, in-process and finished products.
• Manage Environmental Monitoring programs for sterile areas; conduct trend analysis.
• Perform specialized assays including BET/LAL, MLT, BLT, growth promotion and media prep.
• Handle OOS/OOT investigations, CAPA, root-cause analysis and change controls.
• Review SOPs and lab records to ensure compliance with regulatory standards; participate in audits.
• Lead or support regulatory inspections and mentor junior analysts.

Connaissances

Environmental Monitoring

Sterility Testing

OOS/OOT Investigations

CAPA & Change Controls

Regulatory Inspections Experience

Formation

M.Sc. Microbiology / Biotechnology / Life Sciences

B.Pharm / M.Pharm

B.Sc. Microbiology (injectable experience)

Outils

QMS Systems

cGMP/GLP Knowledge

ALCOA+ / Data Integrity

Description du poste

Role & responsibilities

• Testing & Monitoring: Oversee and perform microbiological testing of raw materials, purified water (PW), Water for Injection (WFI), compressed gases, in-process samples, and finished products.
• Environmental Monitoring (EM): Manage cleanroom EM programs for Grade A, B, C, and D sterile areas (air sampling, surface monitoring, and personnel swabbing) and conduct trend analysis.
• Specialized Assays: Ensure accurate execution of sterility testing, Bacterial Endotoxin Tests (BET/LAL), Microbial Limit Testing (MLT), Bioburden Limit Testing (BLT), growth promotion tests, and media preparation.
• Investigations & QMS: Handle Out-of-Specification (OOS), Out-of-Trend (OOT), and deviation investigations, root-cause analyses, Corrective and Preventive Actions (CAPA), and change controls.
• Documentation & Compliance: Review and approve Standard Operating Procedures (SOPs), protocols, and laboratory records to ensure alignment with cGMP, GLP, WHO, USFDA, EU GMP, and Data Integrity (ALCOA+) standards.
• Audits & Team Management: Lead or support regulatory inspections (USFDA, MHRA), customer/internal audits, mentor junior analysts, and manage day-to-day lab operations.

Required Qualifications & Experience

• Education: M.Sc. in Microbiology / Biotechnology / Life Sciences (or B.Pharm / M.Pharm depending on company specs; B.Sc. Microbiology with extensive injectable experience may also qualify).
• Experience: Generally 8 to 15 years of hands‑on experience in sterile injectable microbiology within a USFDA/EU-regulated manufacturing facility, including supervisory or team-handling experience.
• Key Skills: Environmental Monitoring …