Quality Control Analyst at Viatris Egypt

Position summary:

Perform day to day duties in the Microbiology Laboratory, including routine testing, non- routine testing, and environmental monitoring, they are involved in both testing and interpretation of data.
Perform all testing accordance with approved Company Standard Operating Procedures and in an efficient, responsible, accurate and professional manner, co-operating and contributing to the overall objectives of the Company.

Job Specific technical/Functional/Professional Competencies:

Perform routine and non-routine microbiological analysis for finished product, raw materials, waters, and client samples according to the relevant testing procedures and report any problems or queries to the Microbiology supervisor.
Perform environmental monitoring and non-routine monitoring as requested. Report any potential contamination sources to the Microbiology Supervisor. Interpret report and record these results in the appropriate continuous records.
Perform internal calibration, equipment intermediate check and sampling of water if needed.
Perform any routine microbiological lab activities if needed. Communicate and provide support to personnel in other departments, in relation to microbiological issues.
Communicate to and provide support & guidance to team members and assist them in the completion of tasks.
Preform data trending for generated micro results as assigned.
Maintain current qualification status in testing procedures.
Assist in the preparation and updating of SOPs and other controlled documentation used within the microbiology department.
Purify isolates to single colonies using appropriate media and incubation conditions.
Prepare and read wet mounts, Gram stains and Spore stains.
Perform preliminary and confirmatory tests for the identification of microorganisms.
Prepare VITEK cards for identification. Report and interpret results.
Maintain the departmental culture collection. Perform identification of Mould isolates.
Complete prompt and timely investigations of any irregularities concerning isolates identification. Report issues to Microbiology Supervisor.
Use reference materials to source information to confirm identification results.
Purchase of laboratory equipment and supplies to ensure adequate supplies.
Plan and co-ordinate all microbiological activities related to validation studies.
Carry out testing, interpretation and recording of results as per current validation protocols.
Prompt and timely investigation of any irregularities concerning validation testing or equipment calibration.
Proper completion and review of logbooks associated.
Ensure that microbiology laboratory complies with the various regulations governing the pharmaceutical industry and laboratories by always maintaining the laboratory in an auditable condition.
Ensure appropriate standards of cleanliness, tidiness and organization of the work environment is maintained.
Assist with the training of new team members in key team related tasks.
Participate in and take responsibility for workplace environment, health and safety at the level required for this position, following the guidelines in the company Environmental, Health and Safety Management System Manual.
Follow data integrity ALCOA+ principles all over operations and comply with Viatris Quality Standards.
Active implementation of Notification to Management procedures.

Experience and Knowledge

Good command of English in both written and spoken.
Excellent in Microsoft office (word, excel & PowerPoint)
Knowledgeable with interpersonal, good communication and presentation skills.
cGMP & cGLP knowledge is preferred with particular emphasis on Quality Control.
Knowledgeable with microbiological testing techniques and micro lab instruments.

Essential Personal Qualifications

Bachelor’s degree in Pharmacy or Science.
1-2 years’ experience in a related area.
Demonstrated ability to work independently.
Excellent documentation and technical writing skills.
Able to work in a team, interact with various priorities and meet deadlines.
Active, organized and planner with high attention to details.
High observation skills.
Hard worker & self-motivated.

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