Final Product Release Specialist

Job Objective:

Final Product Release Specialist is responsible for the review of manufacturing batch documentation and preparation of the documentation for final product release to the market, as well as being responsible of the management of the final product in the market related to tasks such as complaints, recalls and returns.

Environment:

Internal: Quality Area, Logistics, Manufacturing facility, Administration & Services divisions, and Grifols Egypt for Plasma Derivatives plasma general management.
External: In absence of Final Product Release Manager; sales distributors, Health Authorities, Government Authorities, and auditors.

Key responsibility:

• Revision of manufacturing batch documentation and preparation of documentation for final product release to the market.
• Performance of visual inspections and temperature record reviews of final product.
• Management of customer complaints, product returns and recalls.
• Performance of product recalls simulations.
• Completion and on time closure of deviation investigations, ensuring that robust investigations are performed and appropriate CAPAs implemented.
• Involvement in site quality systems, deviations, change controls, SOPs and self-inspections.
• Actively maintain and promote a cGMP compliant culture, ensuring the compliance with Egyptian Regulation, in accordance to EU and USA requirements and with approved licenses.
• Support regulatory inspections received by Health Authorities.

Academic experience required:

• Bachelors Degree in Health-related Sciences preferably pharmaceutical area.
  
• Comprehensive knowledge and understanding of cGMPs, FDA regulations, and industry guidelines.

Professional experience required:

• Minimum of 2 years of related quality / product release experience in a pharmaceutical, GMP, or FDA regulated environment is required.
• Requires in-depth understanding of pharmaceutical manufacturing, and quality review relating to production batch records.

• Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
• Specific experience with SAP is preferred

Personal skills:

• Ability to work within a highly regulated, labor intensive environment.
• Ability to understand, explain, follow, and enforce SOPs and protocols.
• Ability to plan, communicate and execute activities for the improvement of overall operations.
• Strong integrity and commitment to quality and compliance.
• Ability to work independently with minimum supervision.
• Strong organizational, analytical, and problem-solving skills.
• Must be proactive, results oriented, and have strong attention to detail.
• Ability to effectively prioritize and manage multiple tasks to meet targeted deadlines.
• Strong interpersonal skills with the ability to interact with personnel at all levels in a team environment.

Languages:

• Excellent verbal and written communication skills in the English and Arabic language.