Document Control Specialist

Location: Haarlem, Noord-Holland  |  Sector: Pharmaceuticals  |  Start Date: 9/2/2024  |  Job ref: 53387

The Company
Our client is one of the global leaders in biopharmaceuticals and generics with the drive to provide quality medicines to improve the lives of patients all over the world. With over 100 years of experience in the field, they have curated a wide range of pharmaceutical products used by millions every day.

Role description
The Document Control Specialist is essential in maintaining the accuracy, completeness, and compliance of all production-related documentation with industry standards and regulations.

Responsibilities

-Ensure the precise and thorough completion of BMRs/CVPs, maintaining detailed records of all activities, measurements, and timings throughout the drug manufacturing process.
-Guide operators on accurately completing BMRs/CVPs in alignment with ALCOA++ principles.
-Resolve any discrepancies or missing information by coordinating with the relevant operators.
-Manage the BMR/CVP review process, ensuring it is completed in a timely and efficient manner.
-Collaborate with departments such as Quality Assurance to discuss progress and coordinate the review cycle.

Requirements

-Preferred: 2-4 years of experience as an operator or documentation specialist in a pharmaceutical environment.
-Familiarity with GMP guidelines and ALCOA principles.
-Experience with quality management systems like Track Wise.
-Understanding of BMR/CVP applications in pharmaceutical processes.
-Experience with MES and SAP is a plus

Other Information 
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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.