Validation Expert Analytical Lab

Location:
**Heist op den Berg**
- Type:
**Contracting**

**#19947**

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

**Validation Expert Analytical Lab**

**Location: Heist-op-den-Berg**

**Scope of work**:

- Validation of analytical methods & method transfer
- Set up and write validation protocols
- Analyze the validation results
- Provide conclusions
- Write validation report
- Cleaning Validation
- Sample preparation
- HPLC analysis
- processing of HPLC data with Empower software
- Compendial review
- Assess compendial changes
- Perform method verification
- Training of analysts
- Annual review (reduced testing program): Data analysis + reporting
- Response to internal & external enquiries
- Review data generated by other analysts of the team
- Develop and/or review departmental documentation including lab data sheets, training documentation, SOP's, change controls, deviations and CAPA (Corrective Action/Preventive Action) ensuring compliance with GMP and applicable regulatory guidelines.
- Provide analytical technical expertise in pharmacopeia tests, regulatory requirements, changes, and investigations, root cause analysis
- Share successes with other departments during report out session with management
- Organize and lead method transfer project meetings, attend conference calls + attend daily communication
- Work according to applicable safety guidelines

**Who are you?**
- Master’s or bachelor’s degree in chemistry/sciences/pharmaceutics or equivalent by experience.
- A minimum of 2 years’ experience in an Analytical Lab.
- Experience in the creation of validation protocols, SOP’s, and preparation of validation reports.
- Experience with HPLC (experience on Waters system is a plus)
- Knowledge of Pharmacopeias (USP, Ph. Eur., JP)
- Working knowledge of cGMP requirements.
- Good verbal and written communication skills.
- Ability to work precisely and accurately.
- Team player with ability to work independently and to work in global cross-functional project teams.
- Proactive attitude, taking initiative to help drive the projects forward.
- Strong organizational skills and demonstrated ability to manage projects to completion are highly desired.
- Strong demonstration of problem-solving skills. Open for innovation and proposal of new ideas. Have good creativity thinking skills.
- Ability to understand and extract necessary information from technical documents.
- Ability to effectively manage workload and prioritize activities. Ability to handle multiple tasks simultaneously and to meet critical milestones and goals.
- Strong computer skills, including experience using Microsoft Word, Excel, PowerPoint.
- Good knowledge of the Dutch and English languages

**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**.