Manager / Senior Manager – Microbiology (QC)

SAVA HEALTHCARE LIMITED; Control; Presencial; COP 271.528.000 - 387.898.000; Jornada completa

Descripción de la vacante

A leading health care company is seeking a Manager/Senior Manager for the Microbiology function in the Quality Control department. The role involves overseeing microbiological testing, ensuring compliance with regulatory standards, and leading a team. Candidates should have extensive experience in QC Microbiology within a regulated environment, with strong leadership and analytical skills. This is a full-time managerial position located in Indore.

Formación

• 10–15 years of relevant experience in QC Microbiology in a regulated pharmaceutical environment.
• At least 3–5 years in a leadership/managerial role.
• Certified training in cGMP, Data Integrity, Aseptic Practices, or Sterility Assurance is preferred.

Responsabilidades

• Lead and manage the microbiology team, ensuring training and performance management.
• Ensure compliance with cGMP, GLP, and data integrity principles.
• Supervise all microbiological testing activities and documentation.
• Lead microbial risk assessments for manufacturing processes.

Conocimientos

Microbiological testing methods

Aseptic techniques

Contamination control

Leadership and people management

Analytical skills

Educación

M.Sc. (Microbiology) / M.Pharm (Microbiology)

Descripción del empleo

Job Title: Manager / Senior Manager – Microbiology (QC)

Location: Indore – Regulated Pharma Manufacturing Plant

Department: Quality Control – Microbiology

Reporting To: Head – Quality Control

Job Type: Full-Time | Managerial Level

Job Purpose

To lead the Microbiology function in the QC department, ensuring compliance with current Good Manufacturing Practices (cGMP), regulatory requirements (USFDA, EU-GMP, MHRA, WHO, etc.), and company quality standards by overseeing microbiological testing, environmental monitoring, sterility assurance, and microbiological risk assessments.

Key Responsibilities

• Leadership & Team Management: Lead and manage the microbiology team, ensuring training, development, and performance management. Provide technical guidance to resolve complex microbiological issues.
• Compliance & Regulatory Readiness: Ensure strict adherence to cGMP, GLP, and data integrity principles in all microbiological activities. Prepare and face regulatory inspections (USFDA, MHRA, EU, WHO-GMP) and ensure readiness through gap analysis and internal audits.
• Microbiological Testing Oversight: Supervise And Review All Microbiological Testing Activities Including Environmental Monitoring (EM), Water Testing (WFI, PW, HVAC, Compressed Air), Sterility Testing and Bacterial Endotoxin Testing (BET), Microbial Limit Tests (MLT), Bioburden & Identification of Isolates, Disinfectant Effectiveness Studies and Media Growth Promotion Testing
• Documentation & Quality Systems: Review and approve microbiological protocols, SOPs, specifications, and reports. Investigate microbiological deviations, OOS/OOT results, and implement appropriate CAPAs. Ensure Timely Execution Of Qualifications For Microbiology Lab Equipment.
• Risk Assessment & Process Improvements: Lead microbial risk assessments for manufacturing processes and facility controls. Identify and implement continuous improvement initiatives within the microbiology lab.
• Coordination & Communication: Collaborate with QA, Production, Engineering, and other departments for hygiene, contamination control, and new product support. Provide inputs during product and process changes, validations, and tech transfers.

Key Skills & Competencies

In-depth knowledge of microbiological testing methods and aseptic techniques. Strong understanding of cleanroom classification, contamination control, and regulatory standards. Expertise in sterile and non-sterile product microbiology. Leadership and people management capabilities. Strong analytical, documentation, and communication skills.

Educational Qualifications

M.Sc. (Microbiology) / M.Pharm (Microbiology) or equivalent qualification in a life science discipline.

Experience

10–15 years of relevant experience in QC Microbiology in a regulated pharmaceutical environment, with at least 3–5 years in a leadership/managerial role.

Preferred Certifications / Trainings

Certified training in cGMP, Data Integrity, Aseptic Practices, or Sterility Assurance preferred.