QC Analytical Data Reviewer

Our company

Basic Pharma is a unique Dutch pharmaceutical company that is growing at lightning speed, is constantly building its organization and is constantly specializing and developing. The company focuses on the full breadth of the pharmaceutical industry: from product development, registration, production and commercialization of (bio) pharmaceutical products to pharmaceutical services,

Basic Pharma has an ever-increasing circle of national and international customers, from start-ups to multinationals.
The production organization Basic Pharma Manufacturing makes products such as nasal sprays, filled syringes, creams and ointments. In addition, it also supplies clinical study medications and offers various services to third parties, such as quality control and contract manufacturing.

The availability and combination of all activities under one roof makes Basic Pharma a strong and versatile player within the pharmaceutical industry. Currently there are approximately 250 employees. Basic Pharma's ambitions go further and that is why we are looking for employees who are committed, who consider professionalism of paramount importance and who put the customer first.

Join our QC team to ensure the integrity, accuracy and compliance of analytical and chromatographic data supporting pharmaceutical development. As a QC Analytical Data Reviewer, you will review raw data, reports and laboratory documentation to confirm adherence to validated methods, SOPs, regulatory requirements and best practices, driving quality improvements across the organization.

We are looking for a
QC Analytical Data Reviewer

Key Responsibilities:

Data & Report Review:

• Audit all chromatographic data, logbooks, raw data archives and calibration reports for scientific soundness, completeness and accurate representation of results.
• Evaluate analytical results against methods, protocols, product specifications, SOP acceptance criteria, Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).

Quality Control Documentation:

• Prepare QC statements and Certificates of Analysis for raw and packaging materials.
• Report deficiencies (Out-of-Specification, Out-of-Trend and deviations) clearly to project leads or the QC Manager.

Training & Communication:

• Provide training and retraining to laboratory staff on proper documentation procedures
• Communicate review findings and collaborate with analysts to proactively address data quality and documentation best practices.

Process Improvement & Compliance:

• Advocate for and support process improvement initiatives to enhance data review workflows.
• Ensure compliance with cGMP, cGLP, EU Eudralex Volume 4, FDA guidelines and internal EHS policies; maintain high standards of laboratory housekeeping.

Documentation Management:

• Act as support for archival and sample registration processes to meet production schedules.
• Write and update SOPs, test methods, validated worksheets and related procedures as needed.

What do you bring?

• Bachelor’s degree in Chemistry, Biochemistry, Biotechnology or related scientific discipline.
• 2+ years of QA/QC analytical data review experience, with a strong chromatography background (HPLC, GC, MS, ELISA, etc.).
• (Alternatively) 4+ years QC laboratory experience managing data review processes.
• Thorough understanding of SOPs, GLP, GMP, cGMP, cGLP and EU Eudralex Volume 4.
• Exceptional attention to detail and analytical problem-solving.
• Strong verbal and written communication, with ability to deliver concise feedback.
• Proficiency in Microsoft Office and data-management systems.
• Ability to prioritize multiple tasks and work under pressure.

What we offer:

• A dynamic work environment where you can develop methods and help bring new products from concept to market
• Opportunities for growth and personal development
• Competitive compensation with good secondary employment conditions

Acquisition in response to this vacancy is not appreciated

Vragen over deze vacature?
Neem dan contact op met onze afdeling HR via +31 (0)88 255 40 10 of [email protected].