Hobson Prior are looking for a QC Technical Support to join a world-wide biopharma organisation focused on improving the lives of patients globally through pioneering medicines.
This is a contract position based in Switzerland.Please note that to be considered for this role you must have the right to work in this location.
n nKey Responsibilities : In this role, you will be responsible for acquisition and qualification of new analytical equipment.
Works cross-functionally with the Analytical Development, QC, IT and Validation departments to select, purchase and qualify new analytical equipment for the QC laboratories.
n nOwns the change control, leads or supports risk assessments.Performs feasibility experimental work as needed.Uses scientific and technical expertise to investigate and resolve technical issues in the laboratory.
Owns deviations. Leads or supports laboratory investigations in case of out of specification or out of trend result. n nCan approve laboratory investigation checklists.
Provides guidance for confirmatory testing.Represents QC in cross-functional project teams, interacting with Project Management Office, Manufacturing, Analytical Development, Analytical Science and Technology.
n nSupports QC management in identifying needs for new equipment and assessing impact on laboratory systems and processes as well as on resource planning.
Leads or supports risk assessments, owns change controls.Administers user profiles and access to the systems,Defines requirements and performs audit trail reviews, assures adherence to data integrity principles,Maintains the GMP status of the laboratory and analytical methods.
n nPerforms all activities in compliance to cGMP requirements as well as to EHS rules and safe work practices per applicable procedures.
Evaluates impact of compendial changes on applicable QC procedures and opens change controls as required. n nAny other assigned duties.
Key Skills : Ability to work collaboratively and cross-functionally in project teams.Excellent verbal communication skills, ability to interact with different levels of the organization : supervisor, peers, lab analysts, and other departments.
n nOutstanding 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.
n nRequirements : The ideal candidate will require a BS degree in Life Sciences, Chemistry, or equivalent.A minimum of 5 years of work experience in a GMP environment (pharmaceutical industry).
Advanced knowledge and interpretation of cGMP and Pharmacopeia requirements. n nStrong 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.
n nExperience 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).
n nGood knowledge of Data Integrity principles, familiar with audit trail review requirements.Fluent in English or French and professional command of the second language (written and verbal).
Apply now : If you are interested in learning more or applying to this exciting opportunity then please click "Apply " and upload a copy of your CV.
n nAlternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me " at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe.
n nHobson Prior is acting as an Employment Agency in relation to this vacancy