Final Product Release Specialist
Grifols Egypt for Plasma Derivatives
Employer Active
Posted on 31 Mar
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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
- Pharma
- Biotech
- Clinical Research
Department / Functional Area
- Quality
- Testing
- QA
- QC
- Inspector
Keywords
- Final Product Release Specialist
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Grifols Egypt for Plasma Derivatives
https://www.careers-page.com/grifols-egypt-for-plasma-derivatives/job/3WR7674V