Validation Expert Analytical Lab

Il y a 7 mois


Zaventem, Belgique Jefferson Wells Temps plein

Location:
**Zaventem**
**#22101**

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 join our team.

Let's look together at your first challenge with us

**Validation Expert Analytical Lab**

Scope of work:
**Areas of responsibilities are**:

- Validation of analytical methods & method transfer:

- need to be able to set up and write a validation protocol.
- to analyze the validation results
- provide conclusion.
- 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.

**Profile**:

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

**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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