إرفاق
وصف الوظيفة
- 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.
-
- 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.
المهارات
- Bachelor’s degree in pharmaceutical sciences or science.
- From 3 to 5 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.
المؤهلات العلمية
Pharmacy or Science