Validation Senior Specialist At Orchidia Pharmaceutical Industries

Job description
Preparing and executing the validation activities in the plant according to company quality system and GMP guidelines.

Responsibilities

· 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

Qualifications

· 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.

Interested Candidates send their CVs to ahmed.elnady@orchidiapharmaceutical.com Mentioning position name in subject