Microbiology Head (India)

Microbiology Head (India)

30 Jul
|
Systacare Remedies
|
India

30 Jul

Systacare Remedies

India

Job Description – Department Head (Microbiology Head)

Company: Systacare Remedies
Position: Department Head – Microbiology
Location: Balkalan, Amritsar
Department: Quality Control – Microbiology
Employment Type: Full-time

Job Summary

Systacare Remedies is seeking an experienced and dynamic Department Head – Microbiology to lead the Microbiology Department. The ideal candidate will have solid expertise in pharmaceutical microbiology, regulatory compliance, and team leadership, with mandatory experience in sterile injectable manufacturing. The role involves overseeing all microbiological testing activities, ensuring compliance with GMP and regulatory requirements, and driving continuous quality improvement.

Key Responsibilities

- Lead and manage all microbiology laboratory operations.
- Ensure compliance with GMP, GLP, and applicable regulatory guidelines.
- Oversee environmental monitoring, water system monitoring, utility monitoring, and cleanroom qualification.
- Review and approve microbiological test results, SOPs, protocols, reports, and validation documents.
- Manage sterility testing, microbial limit testing, endotoxin testing, media preparation, and culture maintenance.
- Investigate out-of-specification (OOS), out-of-trend (OOT), deviations, and contamination events, and implement effective CAPA.
- Support regulatory inspections, customer audits, and internal quality audits.
- Ensure laboratory compliance, equipment qualification, calibration, and maintenance.
- Develop, mentor,



and lead the microbiology team to achieve departmental objectives.
- Coordinate with QA,QC, Production, Engineering, and Validation teams for quality and compliance initiatives.

Qualifications

- Master's degree in Microbiology.

Experience (Mandatory)

- Minimum 7–8 years of experience in pharmaceutical microbiology.
- Minimum 3 years of hands-on experience in sterile injectable manufacturing is mandatory.
- Proven experience in leading a microbiology team or department.

Required Skills

- Strong knowledge of microbiological testing and laboratory practices.
- In-depth understanding of sterile manufacturing processes.
- Excellent knowledge of GMP, GLP, data integrity, and regulatory requirements.
- Experience with environmental monitoring programs and contamination control strategies.
- Strong leadership, analytical, problem-solving, and decision-making skills.
- Effective communication and team management abilities.

Preferred Candidate Profile

- Experience handling regulatory inspections and customer audits.
- Demonstrated ability to lead teams and drive continuous improvement initiatives.
- Strong documentation, review, and compliance management skills.

Mandatory Requirement: Candidates must have at least 3 years of experience in sterile injectable manufacturing. Applications not meeting this criterion will not be considered.

Pay: ₹40,000.00 - ₹50,000.00 per month

Work Location: In person

📌 Microbiology Head (India)
🏢 Systacare Remedies
📍 India

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