Beschrijving van de functie At SGS, you can choose.
First of all, out of our various vacancies. However, SGS also gives
you another choice. Do you choose to expand or to enrich? We are
not only looking for colleagues who can go into depths of their
discipline. We are equally as much looking for colleagues who we
call 'connectors', people who can connect our diversity to our
services. To each other. And this way, enrich our business. SGS is
the world's leading inspection, verification, testing and
certification company. We're also the worldwide benchmark for
quality and integrity. And that makes us very proud. This can only
happen thanks to more than 90 000 colleagues worldwide, with 1650
employees in Belgium only. Our employees give 110% of themselves
every day, divided over all expertises, branches and cultures. Our
coworkers build their own way inside the company, the services and
the expertise. The Quality Assurance Department is an independent
department within SGS Pharma. It is responsible for the Quality
Management System, which covers all quality documents, training and
qualification, resolution and documentation of non-conformances,
auditing activities and dedicated quality support to all
operational teams (i.e. Clinical Pharmacology Unit (CPU), Business
Development and Support, Clinical Operations, Biometrics and
Medical Safety & Regulatory). We are currently looking for an
Operational Quality Manager. As Operational Quality Manager (OQM)
you are welcomed in a smaller, amiable, and enthusiastic QA team
where you will have day-to-day interaction with other QA experts in
the field, such as other OQMs, Quality Compliance Managers,
Auditors,. As OQM, you will be an indispensable partner of the
operational teams specifically at our CRO in the management of
their part of the quality system. As such, you will gain further
insight into the CRO activities involved in the conduct of clinical
trials for pharma and biotech companies from start to finish. Your
responsibilities: Your main responsibilities are the following:
Collaborate with the assigned operational teams at the CRO to
improve quality and maintain high quality standards throughout the
organization by: Developing and maintaining operational quality
(SOPs, WIs, CDs, manuals and various guidance documents) and
personnel documents Supporting the teams by providing additional
explanation on topics relating to quality documents/process
improvements, development of trainings (eLearnings, classroom
trainings) together with the QA training department Initiate
process improvements / efficiencies were needed Guide the teams
through the non-conformance management process by assisting in risk
assessment of non-conformances, Root Cause Analyses and formulation
of CAPA Plans Assist the teams in performing their daily work in a
consistent and efficient way Participate in / facilitate
cross-functional discussions and working groups related to any
aspect of quality at the CRO, to create or optimize
cross-functional procedures, or to look for efficiencies in
processes, systems, and collaboration. Support the further
development of the new SGS CR electronic Quality Management System.
Jouw profiel Minimum of 3 years of experience in a CRO or
university research (department, laboratory) setting, or in a
pharmaceutical, biotech, medical devices (or similar) company, or
equivalent by combination of education, training and experience A
strong affinity with computerized systems and technology in general
(including system validation) is considered a significant asset
Good knowledge of ICH-GCP and good documentation practices, and
experience with project management are a plus Fluently writing and
speaking English Excellent communication and problem-solving skills
Strong organizational skills Proficient in writing Good knowledge
of MS office Assertive and motivated Open for discussion and
constructive attitude Strive for quality and eye for detail Stress
resistant and flexible Taalvaardigheden - Nederlands (troef) -
Begrijpen : Vaardig - (C1) - Schrijven : Vaardig - (C1) - Lezen :
Vaardig - (C1) - Spreken : Vaardig - (C1)