Quality Control Analyst at Viatris Egypt
A Microbiologist is required to 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.
A Microbiologist must 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.
Key responsibilities for this role include:
A – Identification Task:
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.
Proper completion and review of associated logbooks.
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.
Ensure adequate supplies of consumables and equipment.
B – Validation & verification:
Verification the performance of validation studies (IQ/OQ/PQ protocols and reports).
Plan and co-ordination of activities related to validation studies.
Carry out testing and interpretation and recording of results as per current validation protocols.
Timely calibration and maintenance of laboratory equipment.
Purchase of laboratory equipment and supplies.
Prompt and timely investigation of any irregularities concerning validation testing or equipment calibration.
Proper completion and review of logbooks associated.
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.
To assist in the preparation of laboratory materials to ensure that the laboratory is adequately provisioned.
Perform internal calibration, equipment intermediate check and sampling of water if needed.
Perform any routine microbiological lab activities if needed.
Assist in the preparation and updating of SOPs and other controlled documentation used within the Microbiology Department.
Ensure all results are accurately and appropriately recorded in the correct location.
Aid and assist other staff members as required.
Ensure that the Microbiology laboratory complies with the various regulations governing the pharmaceutical industry and laboratories by maintaining the laboratory in an auditable condition at all times.
Ensure appropriate standards of cleanliness, tidiness and organization of the work environment is maintained.
Report and investigate variances in test results.
F- Microbiological Support:
Participate in special project work in which the Microbiology Department is involved.
Assist in the successful completion of the activities outlined in the Business Plan of the Microbiology Department.
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.
The collation of all results and trending data, which is used to provide reports as deemed necessary by the Microbiology supervisor.
Maintain current qualification status in testing procedures.
Undertaking training and reading of Standard Operating Procedures as required.
Assist in Microbiology Training Modules for Cleanroom.
Assist with the training of new team members in key team related tasks.
All Viatris colleagues are expected to conduct themselves in line with the Viatris Values, Integrity, Respect for People, Customer Focus, Community, Innovation, Teamwork, Performance, Leadership and Quality.
I- Statutory Obligations:
All colleagues are expected to conduct themselves in line with relevant legislation pertaining to workplace health and safety, discrimination, harassment and bullying.
J-Environmental Health and Safety:
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.
K- Data Integrity:
Responsibility for implementation of Data integrity program in the relevant work area and insure following up ALCOA principles all over operations.
Active implementation of Notification to Management procedures.
Responsibility for compliance with Viatris Quality Standards.
The minimum qualifications for this role are:
Bachelor’s degree in Pharmacy or Science.
1-4 years’ experience in a related area.
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.
Sound knowledge in general laboratory safety aspects
Good understanding of the pharmaceutical regulatory process.
Demonstrated ability to work independently.
Must be able to work in a stressful, on-demand environment and be able to communicate under stress in a non-confrontational, effective manner.
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.