- 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
qualifications As an Analytical Method Lifecycle Expert, here are the 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.
qu'offrons-nous As an Analytical Method Lifecycle Expert, we offer an attractive salary with the following benefits: - Hospitalisation insurance
- 7 euros meal voucher per day
- Reimbursement km or company car
- Monthly allowance (80 euros net per month)
- A 13th month
- Training A rate as a freelancer is also possible.
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Analytical Method Lifecycle Expert - Braine-l'Alleud, België - Randstad
Beschrijving
We are looking for an Analytical Method Lifecycle Expert, for one of our clients based in Braine-l'Alleud/Wavre.
Don't hesitate to contact me : anne- - Life Sciences Wallonie.
This is a contract as a Consultant (employee or freelance): project until 31/12/2024.
responsabilités
As an Analytical Method Lifecycle Expert, here are the tasks you'll do:
