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| Job Ref. ID: |
50585 |
| Job Title: |
Sr. Specialist |
| Division: |
Quality Assurance - Qualification & Validation |
| Country: |
UNITED ARAB EMIRATES |
| Work Location: |
UAE (RAK head office) |
| Job Type: |
Quality Assurance - Sr Specialist |
| Employment Type: |
Full Time Employment (Limited Contract) |
| Job Description: |
| Purpose: |
the role holder is responsible to adhere with the cGMP principles and maintain them in effective manner. Responsible for Qualification/Validation of Facilities, Utilities, Processes, Cleaning, Equipment’s documentation and implementation of Master Plan. |
| Key responsibilities & Accountability: |
Responsible for adhering with cGMP principles & cGDP and maintaining them in an effective manner.
Responsible for the preparation and review of Installation, Operational, Performance, Re qualification and facility qualification protocols and report.
Prepares and reviews of Process validation and cleaning validation protocols and reports.
Prepares and reviews of Validation related SOP’s.
Executes Installation qualification, Operational qualification, performance qualification and re qualifications.
Responsible for the verification of design qualification and related documents to equipment (e.g. URS, FAT and SAT).
Prepares Validation Master Plan.
Responsible for the requalification schedule management
Coordinates with user department for execution of Qualification and Requalification
Coordinates with the external agencies for Qualification and Requalification
Responsible for the operation and calibration of validation instruments
Perform any other task assigned by Team Leader and support colleagues whenever necessary
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| Qualifications: |
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- Education |
4 years Bachelor Degree in Science / Pharmacy
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- Experience: |
At least 6-8 years’ experience in in pharmaceutical industry preferably in Onsite Inspection.
Fluent in English & Arabic (communicating, writing and speaking).
Proficient in MS Office (MS Excel and MS Word, etc.).
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- Training: |
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| Key Competencies: |
In terms of competency you are highly result oriented with strong sense of accountability & ownership.
High on process compliance and implementation skills with strong attention to details.
Must be able to manage tasks and priorities and easily adapt to changing situations.
Strong communication, interpersonal and collaboration skills required.
Motivated, highly organized, focused, and hardworking.
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| Technical Competencies: |
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