Job Details
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Job Description
Compliance :
- Ensures that all manufacturing process is in compliance with Good Manufacturing Practices (GMP), established internal procedures( S.O.P.) and as specified by appropriate international GMP standards (e.g. WHO, EU, FDA).
SOP Management :
- Issues and reviews The Standard Operating Policies (SOP) related to The Technical Directorate (Production, Quality Departments, Warehouse & Engineering)
- Ensures that all Company's Standard Operating Policies (SOP) is complying with the standard agreed format.
Technical Activities
- Authorizes the final product release
- Initiates the product recall & follow up its implementation
- Solves technical problems related to product quality.
- Assists in resolving issues encountered in the assay documentation, Out of Specification Reports (O.O.S.) and Investigation reports.
- Assesses the appropriateness of Corrective Actions Preventive Actions (CAPA) items proposed in assay documentation.
- Works cross-functionally to resolve issues & discrepancies and to develop any preventive actions to secure the products from any incidents that may cause product turning back, recall or even client's complaints.
- Works closely with the manufacturing management to improve procedures related to quality.
- Sets procedures that ensure the correct handling of materials & documents.
- Issues & reviews the Calibration Program.
- Issues & reviews the Validation Program.(Process, equipment, cleaning & system validation).
- Issues & reviews the system for Deviation and Change Control Management.
- Issues & reviews Annual Product Review
- Secures the calibration of all reading devices, as well as the calibration & validation of all equipment by inspecting them on a routine basis.
- Performs self-audits on a regular basis.
- Performs external-audits on suppliers on a regular basis
Complaints:
- Receives and records the complaint.
- Carries out the necessary investigation and route cause identification
- Assigns the Corrective & Preventive Actions and ensures that the complaint file is safely closed.
Job Requirements
Academic Qualifications:
- B.Sc. degree in Pharmacy required.
- M.S. & PhD. Science will be considered.
- Post graduate in Business Management is an asset.
- Must be knowledgeable of W.H.O / ISO/EU/FDA regulations.
- Proficiency of English language (spoken/written).
- Computer Literacy (Internet & Office Software).
Core Competencies:
Quality Focus
- Sense of quality, precision in fulfilling duties & tasks striving to improve quality & performance.
Technical Expertise:
- Having proper relevant technical know-how & expertise.
- Commitment to continuous learning & application.
- High Ability of technical writing & SOP's.
Result Orientation
- Ability to comprehend & set objectives.
- Identify key indicators results.
Analytical Thinking
- Ability to spot problems, use analysis for better understanding of causes & effects.
