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)
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”)
Job Requirements:
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
Objectives
Within the first 2 weeks, you will...
- Gain a comprehensive understanding of WuXiApptec 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. This includes familiarization with testing procedures for
samples, raw materials, drug substances, and drug products. You’ll be
accompanying colleagues through each of the laboratory department:
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, analysing under current processes,
identifying areas for efficiency improvements, and suggesting changes
that could enhance the overall productivity and effectiveness of
testing functions.
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.