V.I.E Qualification & Validation Coordinator – Life Sciences
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
As a Qualification and Validation Consultant your expertise will support the projects of our partners whose activities are established in the production of medicines or health-related products.
You will play a central role in coordinating and executing the validation cycle with the aim of successfully completing projects within the given timelines.
To do so you will:
- Represent the Validation department on various projects;
- Design and implement the best Validation strategy;
- Coordinate project planning with all stakeholders (Production / QA / Maintenance);
- Participate in risk assessment through the drafting of a Risk Assessment;
- Contribute to the definition and drafting of Functional Specifications (FS) and Design Specifications (DS);
- Write protocols coordinate and ensure the proper execution of tests (URS / FAT / SAT / IQ / OQ / PQ);
- Analyze and interpret results in order to draft the corresponding reports;
- Develop training sessions and coach operators in the field; Manage deviations related to validation runs and implement the associated CAPAs.
Qualifications :
- A degree in Engineering a Masters in Bioengineering Industrial Pharmacy or related fields;
- Experience in qualification and validation within a GMP environment;
- Knowledge of production processes in the pharmaceutical industry;
- The ability to work in English as well as French.
- Curious to learn more about production equipment and/or manufacturing processes;
- Organized and meticulous in drafting your GMP documentation;
- Communicative and enjoy interacting with various departments such as Production / Quality Assurance / Maintenance.
Remote Work :
No
Employment Type :
Full-time
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
About Company
?? ?????????? ???????????? ???? ?????????????????????? ?????? ???? ???????????????? ALTEN is committed to meeting the expectations of its stakeholders and anticipating their requirements in the fields of innovation, R&D, and technological information systems. Founded in 1988 and pr ... View more
