Senior Quality Control Analyst

at  WuXi AppTec

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, pH, 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.
• QC representative in transversal project.
• In charge of the support of QC team members (“center of competencies”)

EXPERIENCE / EDUCATION

You have current experience of minimum seven years multifunction testing in the following QC testing sectors as

• Chemistry,
• AS&T,
• Microbiology,
• Stability,

Apply now to take your first step towards living the WuxiApptec Way! We have an inclusive and diverse culture that provides comprehensive benefits, inclusive an on-site restaurant.
WuxiApptec 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.
You 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. The site offers a wonderful natural environment. A private car is highly recommended

THIS ROLE MIGHT BE FOR YOU IF:

• You have a deeply working knowledge with HPLC/UPLC in a regulated environment – MUST HAVE
• You have a proven ability to work independently or as part of a team. - MUST HAVE
• You possess strong troubleshooting and problem-solving skills. - MUST HAVE
• You are force of proposition with concrete and reflected solutions. - MUST HAVE
• You have strong attention to detail & excellent written and oral skills. - MUST HAVE
• You possess deep ethical and commitment values. - MUST HAVE
• You speak fluent English (C1); French is a big plus. - MUST HAVE
• And very important, you understand and have practice on Lean project management and linked planning and reporting tools. - MUST HAVE
• You have a developed knowledge in quality assurance and quality control procedures.
• You have practice with Veeva Vault and Trackwise, LIMS, moreover with all the MS Office applications.
• You are originated from any EU Schengen country - MUST HAVE
• You 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. The site offers a wonderful natural environment. A private car is highly recommended

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, pH, 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.
• QC representative in transversal project.
• In charge of the support of QC team members (“center of competencies”