Laboratory Validation Officer
Job Purpose
As the section head validation, you will play a key for ensuring that all validation/ qualification activities, and compliance processes meet regulatory and internal standards. This role provides critical quality oversight across qualifications, validation, and risk assessment area to ensure compliance with applicable guidelines, you will:
This role reports directly to the QA Manger and requires close collaboration with operational department, IPD team in Inda, and transferring unit in case transfer tech.
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Key Accountabilities
Accountability Cluster |
Major Activities / Tasks |
Validation and Qualification (Morocco Plant)
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Major Challenges
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Key Interactions
Internal |
External |
* Bracketed information taken from Divisional Accountability Matrix/RASCI |
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Dimensions
Ensure Qualification & Validation for all available equipment (69 main equipment) Systeme and Process and cleaning validation, and for future equipment, system and process added. Risk Assessment preparation for product manufactured (4) facility (1) DI. Examination that Storage Conditions for all areas (5 areas) are maintained according to specification and mapping studies for those areas are compliant. |
Key Decisions:
Decisions |
Recommendations |
Ensure Qualification and validation are up to date |
Regularly review Qualification / validation planning |
Coordinate the execution of Qualification / validation / studies activities |
Align with department to execute protocols as per design |
Prepare the risk assessment |
Review all potential risk with cross functional team |
Comments:
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Skills & Knowledge
Educational qualifications:
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Relevant experience:
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Skills:
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