Job Description

Roles & Responsibilities

Establish, maintain and update QMS policies and procedures to ensure that processes meet applicable standards and specifications, provide technical expertise during internal and external audits and manage related corrective and preventive actions.

Key Responsibilities:

• Participate in regulatory authorities and corporate inspections within UPM site, as well participate in providing responses.
• Contact and respond to all regulatory authorities for any requirements.
• Create, Review, and evaluate all documents related to the compliance department (Compliance, Recall, Complaint management, annual product review, self-inspection ).
• Ensuring that work activities are carried out achieving the pre-set performance goals and providing any necessary actions to the direct manager.
• Follow-up on new guidelines and compendial updates, and ensure the update of in-house systems according to new guidelines.
• Perform Quality audits for all quality systems and departments.
• Participate in quality risk management and provide continuous support to all departments.
• Developing, maintaining, and updating the quality system as per GMP.
• Follow-up on the implementation of CAPAs across departments based on timelines and evaluation of the effectiveness of those CAPAs.
• Participate in the investigation of deviations, OOS, and OOT.
• Follow training system and conduct training of employees based on outcomes of trend analysis.
• Participate in process improvement projects.

Qualifications & Experience:

• B.Sc. in Pharmacy, Chemical Engineering, Industrial Engineering , or Science.
• At least two years of experience in a in pharmaceutical industries, Proficiency in written, read and spoken Arabic and English.
• Knowledge in the systems such as ICH, GMP, GLP, WHO
• Knowledge in Quality Requirements (local, regional, EU requirements)
• Troubleshooting & failure investigation.
• Manufacturing processes stages and techniques for pharmaceutical dosage forms (Solids, Semi Solids, and Liquids).
• Able to communicate effectively, build and maintain interpersonal relationships
• Proactively take initiatives and demonstrate a dynamic approach to manage changing business needs and environment
• Ability to manage, develop teams and goals effectively, influence others, and able to reduce conflict in order to preserve a pleasant and productive work environment.
• Statistical Analysis Tracking System

Desired Candidate Profile

Qualifications & Experience:

• B.Sc. in Pharmacy, Chemical Engineering, Industrial Engineering , or Science.
• At least two years of experience in a in pharmaceutical industries, Proficiency in written, read and spoken Arabic and English.
• Knowledge in the systems such as ICH, GMP, GLP, WHO
• Knowledge in Quality Requirements (local, regional, EU requirements)
• Troubleshooting & failure investigation.
• Manufacturing processes stages and techniques for pharmaceutical dosage forms (Solids, Semi Solids, and Liquids).
• Able to communicate effectively, build and maintain interpersonal relationships
• Proactively take initiatives and demonstrate a dynamic approach to manage changing business needs and environment
• Ability to manage, develop teams and goals effectively, influence others, and able to reduce conflict in order to preserve a pleasant and productive work environment.
• Statistical Analysis Tracking System