Compliance Engineer

Location: Haarlem, Noord-Holland  |  Sector: Pharmaceuticals  |  Start Date: 5/16/2024  |  Job ref: 52711

The Company
Our Client offers the world’s largest medicine cabinet – a full spectrum of products, from generics, API and over-the-counter products to specialty and biologic treatments.

Role Description:
The Compliance Engineer oversees all analytical testing required for the production of Cytotoxic and Inhalation drug products. This includes conducting a diverse range of tests on active pharmaceutical ingredients (APIs), excipients, packaging materials, and finished drug products to ensure their quality and stability. Various analytical techniques, such as Gas Chromatography (GC), Ultra-Performance transform infrared spectroscopy (FT-IR), and Ultraviolet-Visible spectroscopy (UV-VIS), are employed for these purposes.

Responsibilities:

-Evaluate, qualify (including validation), and integrate advanced, computerized laboratory equipment (e.g., GC, UPLC/HPLC, FT-IR, and UV-VIS).
-Ensure timely completion of validation documentation, including coordination of contractor activities.
-Communicate project status to stakeholders and senior management.
-Develop training materials, calibration schedules, maintenance procedures, operational protocols, equipment specifications, and various reports (e.g., URS, risk assessments, IQ/OQ/PQ).

Requirements:
–  Minimum of a Bachelor’s degree (HBO) in Chemistry or a related field.
–  Thorough knowledge of laboratory equipment, including calibration, qualification, and validation.
–  4-5 years of experience in the pharmaceutical industry or a comparable GMP environment, with at least 1 year focused on validating laboratory equipment.
–  Proficient in written English for document preparation.

Other Information
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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.