Validation Officer - Mumbai Central, Mumbai, Maharashtra, India - DITRC

DITRC

Verified Company

Mumbai Central, Mumbai, Maharashtra, India

2 weeks ago

Posted by:

Deepika Kaur

beBee Recuiter

Description

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 & facilitysupport 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 systembysystem basis.
Charged with the handoff 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