Senior quality control analyst long term temporary mission, minimum 12 months

Overview As a Senior Quality Control Analyst with a CDMO organization, you will perform a wide variety of chemical or biological analyses on products, in-process materials, or samples in support of the company's quality assurance and quality control program.(This is a 12-month temporary role, with huge probabilities of extension or turning into a permanent role)Responsibilities In this role a typical day might include, but is not limited to, the following:
Performs analytical testing according to raw material and product release specifications (HPLC, GC, UV/VIS, IR, dissolution, p H, conductivity, TOC, titration, weighing, wet chemistry experiments, etc.).
Performs review of analytical data.
Writes and reviews all types of GMP documents (e.g., test method, SOP, WPR, validation protocols and reports, investigation reports, etc.).
Handles deviations and OOS in the applicable software tool.
Handles change control in the applicable software tool.
Supports internal and external audits.
Takes responsibility in method transfer and method validation activities.
Takes responsibility in selection, purchase, and commissioning of new equipment.
Acts as QC representative in transversal projects.
In charge of the support of QC team members ('center of competencies').
Job Requirements:
This role might be for you if:
You have a deeply working knowledge with HPLC/UPLC in a regulated environment - MUST HAVEYou have a proven ability to work independently or as part of a team - MUST HAVEYou possess strong troubleshooting and problem-solving skills - MUST HAVEYou are a force of proposition with concrete and reflected solutions - MUST HAVEYou have strong attention to detail & excellent written and oral skills - MUST HAVEYou possess deep ethical and commitment values - MUST HAVEYou speak fluent English (C1); French is a big plus - MUST HAVEYou understand and have practice in Lean project management and linked planning and reporting tools - MUST HAVEYou have developed knowledge in quality assurance and quality control procedures.
You have practice with Veeva Vault, Trackwise, LIMS, and all MS Office applications.
You are from any EU Schengen country - MUST HAVEYou are living 'closer' to the Neuchatel region, or within a maximum of 1.5 hours commuting by car or train, or can relocate to this amazing region.
A private car is highly recommended.
Objectives Within the first 2 weeks, you will:
Gain a comprehensive understanding of Wu Xi Apptec Quality Control, Quality assurance, and EHS processes and standards, specifically focusing on the nuances of the site testing functions as well as a comprehensive use of all site IT systems linked to the quality control department.
From the third week:
You'll gain practice in the laboratory, including familiarization with testing procedures for samples, raw materials, drug substances, and drug products.
You'll accompany colleagues through each of the laboratory departments:
AS&T, Chemical, Microbiology, Stability, and Packaging.
You'll also start to implement Lean methodologies within the Quality Control department.
From the fourth week:
You'll be ready to be involved in the current planning, analyzing under current processes, identifying areas for efficiency improvements, and suggesting changes that could enhance the overall productivity and effectiveness of testing functions.
Qualifications Experience / Education You have current experience of a minimum of seven years in multifunction testing in the following QC testing sectors:
Chemistry, AS&T, Microbiology, Stability.
Apply now to take your first step towards living the Wuxi Apptec Way! We have an inclusive and diverse culture that provides comprehensive benefits, including an on-site restaurant.
Wuxi Apptec is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, parental status, gender identity, gender reassignment, or any other protected characteristic in accordance with applicable Swiss laws and regulations.
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