Analytical lifecycle Expert

View: 115

Update day: 04-11-2025

Location: Braine-l’Alleud Walloon Brabant

Category: Production / Operation

Industry: Pharmaceutical Manufacturing

Position: Associate

Job type: Full-time

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Job content

Job description:

Providing analytical expertise and day- to- day support to CMO’s on methods and specifications (including implementation & changes of methods, troubleshooting)
Providing support & analytical expertise for out of specification/expectation and complex analytical investigations at vendor site
Reviewing analytical points in vendor deviations (analytical support & expertise for analytical items in Change Controls and assessment of analytical related actions)
Ensuring coordination and oversight on analytical projects related to cGMP requirements at vendors.
Coordinating of cross-laboratory studies, investigative testing and Technological transfer at vendors for analytical package
Performing review of annual stability protocols and reports, results evaluation, trending, and documentation
Ensuring new campaign preparation (including validation campaign) and coordination with the departments
Working closely with Technical Operations teams to ensure that analytical support is provided in an effective and efficient way

Requirements:

Minimum of 5 years working in the pharmaceutical industry in a GMP operational Quality Control /Development and/or Quality Assurance position.
In-depth knowledge and understanding of analytical activities related to quality controls (deviations, method validations, out of specification management, …).
Excellent knowledge of analytical chemistry, analytical techniques and methods applied to active pharmaceutical ingredients and drug products (HPLC/GC/Dissolution/Karl Fisher, Pharmacopoeia and physical methods). Practical laboratory experience is a plus.
Must possess excellent interpersonal, verbal, and written communication skills in English.
Shows great ability to work in a team and demonstrates collaborative mindset. Delivering solutions
Must have the ability to independently analyze data and information, to draw conclusions and make effective decisions.
Has the ability to identify risks and propose corrective actions within areas of expertise.

Offer:

A rate as a freelancer is also possible.

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