Change Control
il y a 3 semaines
Location:
- **Brussels**- Type:
- **Contracting**:
- **#17499**
Will you be our new ambassador?
**Jefferson Wells Life Sciences** specializes in supporting **pharma & biotech companies** in their daily challenges. Hence our interest in **experts** like you to pass our team.
Let's look together at your first challenge with us
**Change Control / cGMP Engineer**
- Our partners innovate to bring _**_treatments_**_ to their patients that significantly improve their lives. Together with the government and other health partners they are working towards _**_qualitative, affordable and accessible healthcare_**_._
For one of our pharmaceutical partners we are looking for a **Change Control / cGMP Engineer**.
**Main Responsibilities**
Responsible for the **technical support of the production process**, **root cause analyses**, **larger projects** etc. and ensure the **coordination and implementation of continuous improvements** within the production department, taking into account all facets within the **cGMP guidelines**, in order to contribute to the core business (production,) can function as optimally and efficiently as possible.
**Context**
The position is performed in a** cGMP environment** and must at least comply with all **quality and safety requirements and industry standards **applicable by the official auditing authorities. This relates to, among other things, **production facilities, product safety, qualification of personnel, procedures & documentation**.
The position must also operate within the company culture, values and norms.
This is in order to be able to **deliver a high-quality, safe and effective product.**
**Position**
- Provide continuous process support and provide both ad hoc and proactive advice, service and technical expertise
- Monitoring processes; adjust and/or escalate where necessary
- Initiating and executing specific investigations into existing and innovative processes and technologies, as well as developing and implementing new (sub)processes and technologies after approval from supervisor
- Writing, revising, providing input and training of operational procedures, assisting in the implementation of new procedures, and ensuring correct compliance with SHE guidelines house rules, GMP guidelines, legal standards, regulations and regulations within own department
- Ensure periodic and ad hoc communication about the state of affairs and the preparation of relevant reports
- Proactively follow trends and developments within your own field, as well as build up and share knowledge within this domain
- Initiating consultations with internal and inter-organizational experts across disciplines
- Maintain, adjust and communicate documentation and process knowledge
**Who are you?**
- Analytical, stress resistant, structured
- Experience in Change Control in GMP environment and/or Deviation handling in a product environment (GMP) (process engineer, change control engineer, cGMP engineer, QA engineer)
- Fulltime, on site work
- Quickly deployable
- Communicative
- Mature
- Pharma experience & Biotech experience
- Experience within Delta V or SAP is an advantage
- Good knowledge Dutch, good knowledge English (writing)
**What can Jefferson Wells do for you?**
As an ambassador you have the opportunity to grow within international companies where you can build a **strong network**. Through a personal **follow-up**, you receive **quality support** in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal **training** and **education**.
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