QA Specialist

Il y a 6 mois

Gent, Belgique MindCapture Temps plein

QA SPECIALIST
- Biotech- GhentWHAT IS OFFERED

We offer strong compensation packages that reward your abilities, hard work and resourcefulness in achieving success.

We reward you with competitive salaries and offer a strong package of additional legal benefits such as meal vouchers, eco vouchers, high health insurance (DKV) and group insurance. Depending on your seniority, a car may be provided.

We offer personalized training to help you grow in terms of
- What you like to do
- What you are good at
- Where and how you want to make an impact

ABOUT THE COMPANY

MindCapture is a talent company specializing in medical devices, pharma and engineering. As a consultant, you will have the opportunity to learn and sample diverse environments. Moreover, we offer personal and professional support, both from MindCapture and from our partner. For this project, we are working with a global market leader within the pharmaceutical industry.

You will enter a culture where ownership is an essential characteristic of every colleague. We want to excel today but also think about tomorrow and respond proactively. To achieve your work, we need each other, help each other, challenge each other and share knowledge.

**Major Responsibilities**:

- The QA Specialist will **support projects and system governance** in QA operation activities.
- Contributes on the **implementation** and subsequent **changes** of a Manufacturing Execution System **(MES)** and / or implementation and subsequent changes of an Enterprise Resource Planning system **(ERP)**:

- Ensure appropriate support and governance of Master Data
- Involvement in general QA operation/system projects
- You are in close contact with multiple departments (Operations, Supply Chain, QC, QA,).
- You will ensure accurate and timely **review and approval of various testings of the system**.
- You will be responsible for **drafting necessary documents**, including Standard Operating Procedures and Work Instructions for the users.
- Monitor and report on progress of the project goals and operational project KPIs
- **Review and approve standard operating procedures and batch records**:

- Ensure accurate and timely maintenance and review of manufacturing investigations, CAPAs, change controls and complaints. Real time review of all documentation and reporting in support of process unit operations and release activities.
- Strive to reduce non-conformances in supported areas by proactively driving compliance.
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
- Support regulatory inspections and audits by ensuring inspection readiness within facility.
- Other duties will be assigned, as necessary.

REQUIRED COMPETENCES & SKILLS
- At least 3 years of experience in a related function = building QA Systems, set-up of QMS, implementation of a software.
- Affinitity with IT Systems
- Experience in a GMP environment
- Experience with review of validation documentation ( preferably MES)
- Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.
- Must be able to create a highly collaborative and inclusive environment necessary for the team to be effective.
- Good written and verbal communication skills are required.
- Ability to collaborate well with stakeholders, customers, and peers.
- Must exhibit strong decision-making ability and think creatively while maintaining compliance and quality.

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