Job Description & How to Apply Below
On the Technical Support team of the Quality Control (QC), we deliver our mission by testing raw materials, drug substance (API), drug product (Bulk) and stability samples for oral solid dosage forms manufactured at the site. The Scientist will provide technical and scientific expertise to support acquisition and qualification of new equipment, investigation and troubleshooting of analytical and equipment issues as well as introduction of new products to the QC laboratories. Additional duties will include performing superuser activities for the laboratory computerized systems, representing QC in cross-functional projects (e.g. for new product implementation) and participating in internal and external audits as Subject Matter Expert (SME).
As the Scientist, you’ll support that goal by….
Bein responsible for acquisition and qualification of new analytical equipment:
Working cross-functionally with the Analytical Development, QC, IT and Validation departments to select, purchase and qualify new analytical equipment for the QC laboratories.
Owning the change control, leads or supports risk assessments,
Performing feasibility experimental work as needed
Configuring user-profiles and methods on the instrument.
Collaborating with Validation and Sourcing to define requirements and contracts for the periodic maintenance and requalification of the equipment.
Using scientific and technical expertise to investigate and resolve technical issues in the laboratory.
Owning deviations. Leads or supports laboratory investigations in case of out of specification or out of trend result.
Writing investigational testing plans to identify laboratory root cause.
Defining corrective and preventive actions (CAPA).
Representing QC in project teams (e.g. for new product introductions to the site)
Representing QC in cross-functional project teams, interacting with Project Management Office, Manufacturing, Analytical Development, Analytical Science and Technology.
Supporting QC management in identifying needs for new equipment and assessing impact on laboratory systems and processes as well as on resource planning.
Leading or supports risk assessments, owns change controls.
Reviewing method transfer plans. Performs or supports feasibility experimental work as needed. Supports method transfer, method verification and method validation activities.
Being Superuser of laboratory computerized systems:
Administering user profiles and access to the systems,
Defining requirements and performs audit trail reviews, assures adherence to data integrity principles,
Authoring instrument/system operating procedures trains QC analysts on use of the system.
Performing master data management activities in computerized systems (LIMS, Oracle, Empower).
Maintaining the GMP status of the laboratory and analytical methods.
Performing all activities in compliance to cGMP requirements as well as to EHS rules and safe work practices per applicable procedures.
Evaluating impact of compendial changes on applicable QC procedures and opens change controls as required.
Actively participating in inspections by health authorities and in corresponding preparation.
Performing other tasks as assigned
BSc Chemistry, Biology, Microbiology or relevant discipline.
Minimum 5 years’ experience in Quality Control/Analytical Research Development in GMP/Pharma environment;
Advanced knowledge and interpretation of cGMP and Pharmacopeia requirements
Excellent scientific knowledge and hands-on experience of chromatography techniques (HPLC, UPLC, GC), dissolution, UV/VIS and IR techniques.
Experience of analytical testing according to Ph. Eur. and USP requirements.
Experience in analytical method transfers and analytical method validation/verification.
Experience in laboratory equipment qualification.
General computer literacy including MS Office (Word, Excel, PowerPoint, Outlook, Visio)
Good knowledge and/or ability to familiarize themselves quickly with new software and computerized systems (specific instrument software, Empower, LIMS).
Good knowledge of Data Integrity principles, familiar with audit trail review requirements.
Effective verbal communication skills, ability to interact with different levels of the organization: supervisor, peers, lab analysts, and other departments
Effective technical writing skills, experience writing GMP documents (procedures, protocols, plans and reports) as well as deviations and investigations.
Takes a structured and analytical approach to problem-solving. Is familiar with problem-solving and investigation tools and methodologies.
Ability to work collaboratively and cross-functionally in project teams.
Fluent in English or French and professional command of the second language (written and verbal)
This position is primarily located at the Celgene site in Couvet.
Less than 1 Year
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