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Job Title: Microbiology Lab Head - Rotabiogen Factory

Company: HPG Pharmaceuticals

Location: 10th of Ramadan, Egypt

Are you a seasoned Microbiology professional with a passion for quality and leadership?

HPG, a leading Egyptian pharmaceutical company, is seeking a dedicated and experienced

Microbiology Lab Head to join our team at the Rotabiogen factory in 10th of Ramadan.

In this critical leadership role, you will be responsible for providing direction and oversight to our microbiology team, ensuring the highest standards of quality control and regulatory compliance for our products. You will play a key part in safeguarding the quality of our raw materials, finished products, and manufacturing environment.

Key Responsibilities:

1. Leadership & Team Management

Lead and manage the microbiology team, ensuring training, development, and performance management.

Provide technical guidance to resolve complex microbiological issues.

2. 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.

3. 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

4. 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.

5. Risk Assessment & Process Improvements

Lead microbial risk assessments for manufacturing processes and facility controls.

Identify and implement continuous improvement initiatives within the microbiology lab.

6. 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 product microbiology.
• Leadership and people management capabilities.
• Strong analytical, documentation, and communication skills.

Who We Are Looking For:

• M.Sc. (Microbiology) / M.Pharm (Microbiology) or equivalent qualification. ( Master's or PhD degree is an advantage )
• Experience:
• +20 years of relevant experience in QC Microbiology in a regulated pharmaceutical environment, with at least +5 years in a managerial role (with a proven certification).
• Preferred Certifications / Trainings:
• Certified training in cGMP, Data Integrity, Aseptic Practices, or Sterility Assurance preferred.
• Expert in sterile product microbiology.

Why Join HPG?

At HPG, we are committed to providing a dynamic and supportive work environment where you can grow your career and make a real impact. You will be part of a forward-thinking team dedicated to producing high-quality pharmaceuticals that improve lives.

If you are a results-driven professional ready to take on a new challenge and lead our microbiology section to success, we encourage you to apply.

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