Final Product Release Specialist (New Capital) at GRIFOLS, S.A.

Cairo, Cairo, Egypt -

Full Time

Start Date

Immediate

Expiry Date

01 Jun, 26

Salary

0.0

Posted On

03 Mar, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

cGMPs, FDA Regulations, Batch Documentation Review, Quality Inspections, Complaint Management, Recall Management, Deviation Investigations, CAPA Implementation, Change Controls, SOPs, Self-Inspections, Regulatory Inspections, MS Office, SAP, Analytical Skills, Problem-Solving

Industry

Pharmaceutical Manufacturing

Description

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. Key responsibility - Revision of Manufacturing batch documentation and preparation of documentation for Final Product release to the market. - Performance of Quality inspections of Final product, including storage and transportation temperature record review. - Management of Customer complaints, Final 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 requirements and approved licenses. - Support Regulatory inspections received by Health Authorities or external parties. Academic experience required - Bachelor's Degree in Health-related Sciences 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. Computing skills - 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.

Responsibilities

The specialist reviews manufacturing batch documentation and prepares materials for final product release to the market, while also managing post-market activities such as customer complaints, returns, and recalls.