Assistant Manager Microbiology

About the role

We are looking for an Assistant Manager Microbiology to lead microbiology operations at our site, ensuring timely analysis of raw materials, finished products and stability samples while maintaining compliance with QMS and regulatory requirements.

Key responsibilities

• Perform and verify microbiological analyses of oral finished products, stability samples and raw materials, including ampoule, eye‑drop and cephalosporin testing.
• Ensure accurate documentation, logging of results and preparation of compliant reports.
• Support development, review and implementation of SOPs, conduct gap analyses against GQMPs, GQPs, USP and CAPA requirements.
• Provide GPS and EHS support across laboratories.
• Represent and ensure Data Integrity compliance for all microbiology laboratory systems and records.
• Maintain, qualify and schedule calibration of microbiology equipment in line with AEQMS requirements.
• Perform environmental monitoring and document results according to standards.
• Oversee microbiology labs, method validation and support process validation activities.
• Manage culture maintenance, inventory, raise purchase orders in SAP and supervise third‑party service providers.
• Prepare trend and summary reports, assign laboratory tasks, conduct audit‑trail reviews and act as microbiology SME during audits.
• Drive continuous improvement projects, maintain microbiology KPIs and undertake any additional responsibilities as required.

Required profile

• BS in Microbiology, Biotechnology or equivalent.
• Minimum 3‑5 years of relevant microbiology testing experience in a regulated environment.
• Expertise in microbiological operations and testing according to regulatory and QMS requirements.
• Proven ability to lead microbiology lab operations and ensure compliance.

Required skills

• Microbiology testing
• Data Integrity
• GxP regulations
• Lean Management
• Quality Assurance (QA)
• Quality Control (QC)
• Risk Awareness
• Testing Operations
• MS Office (Word, Excel, PowerPoint)
• SAP

What we offer

• Opportunity to work within a global biopharma leader.
• Exposure to cutting‑edge sterile product development.
• Career development and continuous improvement projects.