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 a Documentation Specialist, you will verify and control batch documents, label packages, and logbooks per cGMP, ensuring timely material consumption or notifying the responsible person.
Responsibilities
- Ensure QA-issued documents are accurate and complete.
- Identify and report compliance gaps in the controlled issuance process.
- Implement strategic improvements for the controlled issuance process.
- Support and investigate deviations in the process and develop corrective action plans.
- Perform additional assigned duties.
- Duties can be delegated to qualified deputies when needed.
- Show strong prioritization skills and meet deadlines.
Requirement
- HBO or WO level education.
- At least 2 years of experience in document management within a regulated environment.
- Advanced English communication skills.
- Strong technical knowledge of GMP.
- Ability to clearly present and explain document issuance operations and guidelines to various internal audiences.
- Skilled in cross-training colleagues and customers.
Other Information
Apply to our vacancy for more details. Looking forward to chatting with you!
54331
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About us
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.