Final Product Release Specialist

Grifols Egypt for Plasma Derivatives

Employer Active

Posted on 31 Mar

Experience

2 - 7 Years

Job Location

Cairo - Egypt

Education

Bachelor of Science

Nationality

Any Nationality

Gender

Not Mentioned

Vacancy

1 Vacancy

Job Description

Roles & Responsibilities

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. u> br> /u> /strong>

u>Computing skills/u> /strong>

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

u>Personal skills/u> /strong>

- 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.

u>Languages/u> /strong>

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

Desired Candidate Profile

u>Academic experience required/u> /strong>

- Bachelor's Degree in Health-related Sciences pharmaceutical area.
- Comprehensive knowledge and understanding of cGMPs, FDA regulations, and industry guidelines.

u>Professional experience required/u> /strong>

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

Company Industry

Department / Functional Area

Keywords

  • Final Product Release Specialist

Disclaimer: Naukrigulf.com is only a platform to bring jobseekers & employers together. Applicants are advised to research the bonafides of the prospective employer independently. We do NOT endorse any requests for money payments and strictly advice against sharing personal or bank related information. We also recommend you visit Security Advice for more information. If you suspect any fraud or malpractice, email us at abuse@naukrigulf.com