Scientific Officer - QC (Micro Section)

Key Responsibilities:

• Environmental Monitoring:

  Conduct routine environmental monitoring of Quality Control, Production, and Warehouse areas, including but not limited to, viable and non-viable particle counting, surface sampling, and air sampling, all in strict adherence to approved procedures.

• Sampling:

  Perform accurate and timely sampling of Active Raw Materials (ARMs) and Inactive Raw Materials (IRMs), as well as final lot samples of finished products, according to established protocols.

• Microbiological Analysis:

  Execute microbiological analysis of various samples, including environmental swab samples and compressed air samples, utilizing validated methods.

• Trend Analysis & Reporting:

  Prepare and submit comprehensive monthly and annual microbiological trend summary reports for environmental monitoring procedures, identifying any deviations or critical trends.

• Documentation & Compliance:

  Maintain meticulous logbooks within the Quality Control department, review generated reports for accuracy and completeness, and actively participate in the preparation and revision of Standard Operating Procedures (SOPs).

• Media Fill Support:

  Participation in media fill, sample incubation and perform diligent vial observation to assess aseptic processing performance.

• Team Collaboration:

  Collaborate effectively with cross-functional teams and proactively take on any additional responsibilities assigned by the Head of Department to support overall QC operations.

Qualifications:

• Bachelor's or Master's degree in Microbiology, Biotechnology, or a related scientific discipline.
• 1-5 years of experience in Quality Control Microbiology, preferably within a pharmaceutical, vaccine, or sterile manufacturing environment.
• Proficient in environmental monitoring techniques, microbiological testing, and aseptic practices.
• Strong understanding of cGMP guidelines and regulatory requirements for pharmaceutical manufacturing.
• Excellent data analysis, report writing, and documentation skills.
• Ability to work independently and as part of a team in a fast-paced environment.
• Detail-oriented with a strong commitment to quality and compliance.