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Senior Quality Control Analyst

2 weeks ago

مصر, Egypt Viatris Full time

3803 Viatris Egypt S.A.E
- At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.
Viatris empowers people worldwide to live healthier at every stage of life.
We do so via:
Access - Providing high quality trusted medicines regardless of geography or circumstance;
Leadership - Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership - Leveraging our collective expertise to connect people to products and services.

Every day, we rise to the challenge to make a difference and here’s how the (Senior QC Analyst ) role will make an impact:

- 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.
- C- Analysis:

- 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.
- D- Administration:

- 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.
- E- Compliance:

- 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.
- G-Training:

- 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.
- H-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.
- I- 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.
- J- Other:

- Delegate for Microbiology Section head in case of his absence (if needed).
- Delegate Microbiologist in case of absence.
- The minimum qualifications for this role are:

- Bachel