Documentation Specialist

Location: Hoofddorp, Noord-Holland  |  Sector: Biotechnology  |  Start Date: 1/27/2025  |  Job ref: 54326

Documentation Specialist  

The company
Our client is an international healthcare company specialized in women health. Their mission is to deliver impactful medicines and solutions for a healthier every day.

Role Description
As documentation Specialist you will be responsible for verify and control issued batch documents and label packages including Final product labels per cGMP, as requested by operational departments, as well as verify issued logbooks. 

Responsibilities 
- Responsible for verification of controlled issued logbooks.
- Responsible from timely consumption of consumables/GMP materials used or informing the responsible person.
- Ensure accuracy and completeness of QA issued documents.
-  Identify and escalate compliance gaps across the controlled issuance process.
-  Execute strategic initiatives to improve the controlled issuance process.
- Support/investigate deviations on controlled issuance process and develop effective corrective action plans.
- These duties can be delegated to designated deputies of a satisfactory qualification level as needed.
 
Requirements
-  Holding BSc or related 
- 2+ years’ experience on document management in a regulated environment. 
- Demonstrates advanced technical knowledge GMP. 
- Demonstrates the ability to clearly and concisely present/ explain document issuance operation and its requirements / guidelines to multiple internal audiences.
- Demonstrates ability to cross train colleagues and customers.
- Demonstrates the ability to think outside of the process and consider the impact decisions will have on other areas.

Other information
Are you ready to a new step in your career. Feel free to contact me or apply below. 
We will only consider candidates living in The Netherlands. 
 

54326

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Since 2012, SIRE Life Sciences is the most innovative and engaged consultancy company for the life sciences industries.

SIRE Life Sciences is proud of its ability to adapt to changing trends while always maintaining the highest level of quality for both our clients and our candidates.

Our team of knowledgeable professionals provides customized staffing services to clients and candidates, including secondment, direct hire, temporary-to-hire, temporary staffing, brokering, Statement of Work and we approach each type with the same degree of professional assessment. Our refined and collaborative style is unmatched in the staffing industry. We’re able to see beyond the surface to create matches that result in successful careers for our candidates and valuable talent for our clients.

Effective employment solutions need to put the right person in the relevant place every time, using advanced systems to streamline costs and time-frames for clients.