analytical method lifecycle expert - 10158.

As an Analytical Method Lifecycle Expert, you will provide operational and general analytical support to the Vendor (CMO) management team.

This will be achieved through close partnering with Quality control and Quality assurance management at vendor sites and collaboration with client's Corporate Analytical Sciences, client's External Manufacturing and

other client's teams.  You provide expert advice, operational and general support for global analytical methodslifecycle management of the client's products.

You will contribute by : 

• Providing analytical expertise and day to day support on methods and specs to CMO’s (including implementation & changes of methods, troubleshooting),
• Reviewing analytical points in deviations (analytical support & expertise for analytical items in Change Controls related to CMO’s and assessment of analytical related actions),
• Providing support & analytical expertise for OOS/OOE investigation,
• Providing ad hoc support in case of complex analytical investigation for release or stability testing at a client or a CMO site,
• Performing review of annual stability protocols and reports, results evaluation, trending and documentation in source,
• Working closely with Technical Operations teams to ensure that analytical support is provided in an effective and efficient way,
• Performing review of Analytical data in PQRs,
• Managing analytical documentation access for CMO’s (Specs/Methods/…),

• Minimum of 5 years working in the pharmaceutical industry in a GMP operational QualityControl /Development and/or Quality Assurance position.
• In-depth knowledge and understanding of relevant areas of commercial requirements, inparticular related to quality controls (deviations, method validations, out of specificationmanagement, …).
• Excellent knowledge of French & English.
• Experience interacting with third party organizations with respect to QC/QA systems.
• Excellent knowledge of analytical chemistry, analytical techniques and methods applied toactive pharmaceutical ingredients and drug products (HPLC/GC/Dissolution/Karl Fisher,Pharmacopoeia and physical methods). Practical laboratory experience is a plus.
• Possess high level of problem-solving abilities as well as analytical troubleshooting forlaboratory support and lab investigations.
• Must be able to act under minimal supervision on routine task and handle complex/difficult situations with supervision. Output from actions will most likely impact activities across several departments.
• Shows great ability to work in a team and demonstrates collaborative mindset.

Consultancy

We offer an attractive salary with extra-legal advantages: 

• Group insurance
• Hospitalisation insurance
• Meal vouchers of 7 euros gross per working day
• Reimbursement km or company car 
• Monthly allowance (80 euros net per month)
• A 13th month
• Training
• Etc.

A rate as freelance is also possible