QA - Validation Specialist (Process & Cleaning)

• Assure of the conforming of the facility, utilities, equipment and machines to perform the validation activities.
• Analyze all needed data and prepare reports for quality assurance supervisor.
• Prepare plan for revalidation activities
• Supervise qualification activities during execution.
• Prepare validation plans/protocols in cooperation with concerned departments for the production processes such as:
• Process validation.
• Cleaning validation.
• SIP validation.
• Filtration validation.
• Any relevant activities required by the regulatory authorities.
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• Prepare VMP for the facility as per latest guideline.
• Prepare all documents/SOPs needed for different validation activities.
• Review all supportive documents needed during the validation processes.
• Supervise the investigation team in items related to validation and qualification activities
• Prepare action plan.
• Participate in CAPA system.
• Follow up implementation.
• Work through, follow and adhere to safety instructions and requirements.
• Work according to GLP, GMP and GDP rules.
• Shall be consulted and participated in the EHS management system and its improvement elements.

• Bachelor’s degree in pharmaceutical sciences or science.
• From 3 to 6 years of experience in pharmaceutical industry and operations.
• Understanding of methodologies and best quality assurance practices.
• Knowledge of documentation reviews and requirements analysis.
• Ability to troubleshooting and resolving complex issues effectively.
• Ability to work well through others.
• Ability to meet workloads and project deadlines.
• Excellent English, verbal / written communication.
• Excellent computer skills.

Validation (Process & Cleaning)