Validation Senior Specialist At Orchidia Pharmaceutical Industries
Preparing and executing the validation activities in the plant according to company quality system and GMP guidelines.
· Assure of the conforming of the facility, utilities, equipment and machines to perform the validation activities.
· Analyze all needed data and prepare reports for QA section head
· 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:
1. Process validation
2. Cleaning validation
3. SIP validation
4. Filtration validation
5. 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:
1. Prepare action plan
2. Participate in CAPA system
3. Follow up implementation
· Bachelor degree in pharmaceutical science or chemistry
· From 3 to 5 years of experience in validation field in pharmaceutical industry.
· Ability to troubleshooting and resolving problems.
· Excellent English, verbal / written communication.
· Excellent in word, excel, internal navigation and SQC.
· Ability to work well through others.
· Excellent computer skills.