Validation Lead

Summary:

Assure the Compliance of implementing all Validation & Qualification plans of company’s related activities effectively & efficiently inside & outside the company towards written procedures, GxP standards & legal regulations.

Job requirements:

·       Monitor all company’s related Validation & Qualification activities to ensure that they are complying with the written procedures.

·       Review Validation Master Plan, which includes all Validation & Qualification activities prior approval to ensure that they are covering all company’s related internal & external activities.

·       Follow-up implementation of all internal & external Validation & Qualification plans to ensure smooth running of the system according to the specified schedules.

·       Review all validation & qualification protocols & reports to ensure their compliance with the written procedures, which are complying with the international standards & legal regulations.

·       Review Change Control Requests & impact action plans to make sure requirements are met & the system will remain in its validated state.

·       Assure the follow-up on the completion of all required change control actions within due dates to make sure the system remains under adequate control.

·       Review BPRs to make sure that they are complying with the latest validated procedures.

·       Review internal and external SOP’s to make sure they comply with the requirements of the GxP regulations and/or requirements.

·       Review required risk assessments to study cause/ impact of an event and make sure the required control measures are adequate to reduce/ eliminate associated risk.

·       Arrange and organize Validation & Qualification tasks with Validation & Qualification and supervise their work to assure the correctness, orderly and timely completion of Validation & Qualification tasks.

Communicate notes and remarks with QA Manager to get timely feedback on related issues.

Qualifications:

Years of Experience: 7

Posting Date: 27 July 2022

Application End Date: 17 August 2022

Available Vacancies: 1

Job Level: Lead

Function: QA - Validation

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