Validation & Calibration Specialist

4 days 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 (calibration and validation specialist) role will make an impact:
Key responsibilities for this role include:

- Run validation project execution DQ/IQ/OQ in conjunction with relevant stakeholders ensuring timelines are met and deliverables achieved.
- Responsible for leading and executing Validation strategies (Validation Plans, Validation Protocols, Validation Reports) for key site Equipment, Systems and Utilities, in line with current regulatory requirements, corporate policies and local site procedures.
- Participates in teams assembled to specify, install, validate, troubleshoot, and maintain systems, processes, or equipment.
- Perform special projects as assigned by department manager and performs other duties to support the engineering department.
- Assist with validation activities performed by outside validation companies, perform job responsibilities in compliance with cGMP, regulatory requirements, company policies and standards.
- Responsible for executing revalidation activities for Equipment, Systems and Utilities whenever needed and ensuring that a continuous state of validation is maintained for site Equipment, systems, and utilities, including providing validation input for any related change controls.
- Investigate deviations which occur and provide solutions or recommendations for changes and/or improvements.
- Understand and extract the needed data from engineering drawings, specification diagrams and maintenance manuals.
- Ensuring all instrumentations are compliant with the site calibration plan, non-routine calibration, and fast acting to support production and maintaining all calibration documentations up to date.
- work in a safe manner and in compliance with all Viatris EHS policies, standards, and procedures

The minimum qualifications for this role are:

- BS in Engineering or Pharmacy or related science and 5 plus years related experience and/or equivalent combination of education and experience.
- Knowledge of cGMP and internal SOPs and general knowledge of associated industry and regulatory guidance documents.
- Ability to read, analyze and interpret common scientific and technical reports, equipment manuals and translate operational limits into protocols acceptance criteria; able to readily identify/report deviations to the department head in a timely manner.
- Experience in Equipment, HVAC & utility systems would be preferred
- Good working knowledge of Microsoft Office (Word, Excel, Outlook, Access, and Projects)

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

Viatris is an Equal Opportunity Employer.

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