QC Microbiology Senior Specialist

Posted 2 Days Ago
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Hiring Remotely in Cairo, EGY
Remote
Senior level
Pharmaceutical
The Role
Perform microbiological testing and environmental monitoring for raw materials, packaging, products, and utilities; review media preparation, method validation, calibration, sterilization, documentation; investigate OOS/OOT/deviations and support CAPA to ensure GMP compliance.
Summary Generated by Built In

Arcera is a global life sciences company headquartered in Abu Dhabi, United Arab Emirates. Our purpose is to enable longer and healthier lives while creating sustainable growth. We develop, manufacture, and commercialize a broad range of high-quality innovative and proven medicines in key international markets. With an operational footprint spanning over 90 countries across four continents, and manufacturing sites in eight countries, we offer more than 2,000 medicines across various therapeutic areas worldwide.

As QC Microbiology Senior Specialist, you will detect and analyze the presence of micro-organisms in various areas of the manufacturing environment and perform microbial testing on sterile and non‑sterile products, raw materials, primary packaging materials, and utilities to ensure compliance with quality standards. The job holder will be report to the Microbiology Lab Section Head. Job holder will perform their responsibilities on site in our factory located in EL Obour City.

Your responsibilities:

  • Analyse and review the samples of different manufacturing areas to test the microbiological attributes for the environmental conditions of working area, water stations, raw and primary packaging materials, finished products to ensure the compliance with the required specifications, all analysis results.
  • Follow-up and review on media preparations used in the microbial testing to ensure its validity to be used on microbial analysis.
  • Perform and review microbial test method validation.
  • Prepare and review all documents related to microbiological analysis.
  • Follow-up and review sanitization and sterilization processes in microbiology lab.
  • Perform and review daily calibration for microbiology lab equipment.
  • Participate investigations and out of specifications related to microbiological issues.

Qualification and Experience:

  • Bachelor’s degree of Science (Microbiology) or Pharmacy
  • Work experience: 5+ Years hands on experience in the Micro filed within pharmaceutical industry or FMCG 
  • Experience in investigation of OOS, deviation, OOT, and CAPA
  • Experience in Method validation and microbiology qualification activities
  • Good understanding of GMP, Data integrity, pharmacopoeia requirements
  • Microbiological testing & environmental monitoring
  • Sterilization and contamination control
  • Equipment calibration & lab operations
  • Documentation & data analysis skills
  • Excellent English language is a must

This is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting, we would love to hear more about you!

Skills Required

  • Bachelor's degree in Microbiology or Pharmacy
  • 5+ years hands-on microbiology experience in pharmaceutical industry or FMCG
  • Experience investigating OOS, OOT, deviations, and implementing CAPA
  • Experience in microbiological method validation and qualification activities
  • Good understanding of GMP, data integrity, and pharmacopoeia requirements
  • Experience with microbiological testing and environmental monitoring
  • Knowledge of sterilization and contamination control
  • Experience with equipment calibration and lab operations
  • Strong documentation and data analysis skills
  • Excellent English language skills
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The Company
HQ: Zurich
2,413 Employees
Year Founded: 1836

What We Do

Acino is a Swiss pharmaceutical company headquartered in Zurich, with a clear focus on high-growth markets. We deliver quality pharmaceuticals to promote affordable healthcare and leverage our high-quality pharmaceutical manufacturing capabilities and network to supply leading companies through contract manufacturing and out-licensing. For more information: www.acino.swiss *** By engaging with Acino on LinkedIn (or any other Acino social media channel), you are agreeing to our Social Media Community Guidelines. If you do not agree to them, do not engage with Acino on social media. Please read our detailed community guidelines carefully here: https://acino.swiss/social-media-community-guidelines ***

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