Validation Officer

1 week ago

Mumbai Central Mumbai Maharashtra, India DITRC Full time

**Required for Saudi Arabia**

**Experience**

A minimum of 5 years of experience in a related field.

**Language**

Good written, read and spoken Arabic and English.

**Professional Knowledge**
- International and EU Regulations
- GMP/GDP
- Validation and Qualification of Equipment and systems

**Executing plans and programs**
- Participating in the development and maintaining the Site Validation Master Plan.

**Duties and Responsibilities (But not limited to)**

**Executive & Technical Duties**
- Primary responsibilities include validation protocol execution (IQ, OQ, PQ, & PV), data analysis and final report preparation for utilities, equipment, and instrumentation.
- Assist in the development of CQV project planning in accordance with project design documentation, equipment specifications, etc.
- Write and review protocols, summary reports and other documentation associated with validations.
- Support facility certification for new manufacturing (process equipment & facility-support equipment) and Quality Control facilities as needed as well as the continued operation of such facilities.
- Ensure systems and processes are validated in a compliant manner in accordance with SFDA, FDA, & EU requirements.
- Actively participate in cross functional teams to determine the root cause and corrective actions for problems associated with investigations.
- Ensure change control activities for systems are completed in compliance with SFDA, FDA, & EU requirements.
- Identify and develop the scope of work required per systems.
- Oversee and track the development of URS on a system-by-system basis.
- Charged with the hand-off of systems between vendors and contractors.
- Ensure effective and active communication with stakeholders, project managers, on all project updates, progress, risks, resolutions, budget, contractor, and vendor statuses, change requests, etc.
- Ensure all required documentation is recorded in a timely and efficient manner and meets regulatory and quality guidelines and GDP.
- Cleanroom gowning.
- Maintain training and qualifications.

**General Administrative Duties**
- Developing periodic reports related to the validated state of facility and equipment.
- Other duties/tasks as assigned by manager

Pay: From ₹250,000.00 per month

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