Executive - QC Microbiology

Role Overview

This position requires an experienced microbiology professional responsible for quality control activities including sterility testing, validation, and equipment qualification within a pharmaceutical context.

Key Responsibilities

• Conduct sterility and Bacterial Endotoxin Testing (BET) on raw materials and finished products.
• Execute validation procedures including preparation and evaluation of SOPs, STPs, validation protocols, and detailed reports related to microbiology.
• Perform equipment qualification activities such as Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Requalification (RQ), and Process Validation (PV).
• Manage calibration tasks associated with microbiology instruments and equipment.
• Initiate and oversee Change Control processes, handle deviations, and coordinate Corrective and Preventive Actions (CAPA).
• Perform bioburden assessments for water, raw materials, and products to ensure microbial limits compliance.
• Carry out population determination tests of biological indicators.
• Conduct testing related to cell banks to maintain quality standards.

Experience and Education

• Experience: 5 to 8 years in relevant microbiology roles.
• Educational Qualification: Postgraduate degree in Microbiology or Biotechnology.

Desired Competencies

• Innovation and creativity in problem solving.
• Strong focus on results and outcome orientation.
• Effective collaboration and teamwork.
• Customer-centric mindset.
• Ability to develop talent within teams.
• Strong stakeholder management skills.
• Strategic agility to adapt to evolving processes.
• Commitment to process excellence and quality standards.