Senior Microbiology Specialist

18 hours ago


Alexandropolis Greece Greece Pharmalliance Consulting Full time €60,000 - €120,000 per year
Position Overview:

We are seeking an experienced and dynamic Senior Microbiology Specialist to join our aseptic ophthalmic manufacturing facility. The successful candidate will play a pivotal role in leading microbiological quality activities, providing expertise in aseptic processing, contamination control, and microbial risk management.

This senior role requires strong leadership capabilities to manage and mentor teams, perform complex investigations, and ensure compliance with global regulatory standards including FDA, EMA, and PIC/S.
Key Responsibilities:
  • Leadership & Team Management:

    • Drive team performance through training, coaching, and development initiatives to enhance microbiological competency.
  • Microbiological Quality Assurance:

    • Serve as the Subject Matter Expert (SME) for microbiology, aseptic processing, and contamination control strategies.
    • Oversee environmental monitoring (EM), clean room qualifications, and aseptic process simulations (APS/media fills).
  • Quality Risk Management (QRM) & Root Cause Analysis (RCA):

    • Lead complex investigations, root cause analyses, and implement corrective and preventive actions (CAPAs) related to microbiological issues​.
  • Compliance & Regulatory Affairs:

    • Support regulatory inspections and audits, providing expert microbiological insights and responses to regulatory agencies.
  • Data Analysis & Batch Review:

    • Review microbiological data trends, interpret raw data, and provide scientific rationale for data deviations​.
    • Perform batch record reviews to ensure microbiological quality requirements are met before batch release​.


Requirements
Key Requirements:
  • Education: Bachelor's or Master's degree in Microbiology, Biotechnology, or a related Life Sciences discipline.

  • Experience: Minimum of 10 years of microbiology experience in the pharmaceutical/biotechnology industry, with at least 5 years in aseptic manufacturing environments.

  • Certifications: QP (Qualified Person) eligibility or trainee status is highly desirable.

  • Technical Expertise:

    • Strong knowledge of aseptic processing, cleanroom contamination control, environmental monitoring, and sterilization techniques.
    • Proficient in quality systems (TrackWise, LIMS, SAP) and regulatory guidelines (EU GMP Annex 1, ICH Q9, FDA guidance).
  • Skills:

    • Strong leadership and team management skills.
    • Excellent problem-solving, analytical, and decision-making abilities.
    • Effective communication and interpersonal skills, capable of influencing cross-functional teams.

Desirable Attributes:
  • Proven experience in ophthalmic or sterile product manufacturing environments.
  • Hands-on experience with regulatory inspections (FDA, EMA, MHRA).
  • Strong background in data trending, deviation management, and CAPA implementation.


BenefitsWhat We Offer:
  • Sunny Greek location. 
  • Competitive salary and expense package.
  • Opportunities for professional development and career growth.
  • A dynamic work environment committed to quality and innovation.



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