Senior Qualitiy Expert/Compliance Lead (Ref. Nr.: EW2625)
Posted on Sep 20, 2019 by BRINE SA
BRINE SA has been placing top IT specialists at well-known customers for over 30 years. In doing so, we focus on performance, competence, experience and partnerships.
- OMA Compliance & Governance Training
- Lead design and implementation of Just-In-Time (JIT) training concept for OMA in 3Q
- Operate and monitor execution of JIT training in 4Q+
- Advise Pharma Medical Affairs on JIT training implementation (TBC)
- Support OMA Global GxP Director on training management and operations (incl assignments and training compliance monitoring)
- Provide ad-hoc support to key projects (namely GEMS rollout, HCP Experience)
Professional and Technical Requirements
- Minimum: Scientific qualification (PhD, MSc or Bachelor's Degree) in in an appropriate scientific discipline or quality-related field with an in-depth knowledge of the international pharmaceutical product development process
- A minimum of 2 years' experience with GxP requirements, quality management system including risk management and regulatory requirements from main Heath Authorities.
- Expertise in the principles and practices of Quality Risk management and/or GxP audits
Experience, Skills, Knowledge:
- Strong analytical and planning skills
- Able to understand and work with enterprise and functional systems & data
- Experienced in implementing and deploying projects/changes in an organization
- A broad understanding of Quality Management, GCP/GVP and Risk Management processes
- A broad understanding of main Health Authorities standards (eg FDA, EMEA) and ICH regulations and guidelines.
- Proven self-starter with experience in building capabilities based on defined business needs across geography and functions.
- Fluent in written and spoken English. Strong and confident communicator both internally at all levels and externally with outside and industry bodies.
- Must have is Pharma experience; FDA Knowledge is an Advantage
- Should be familiar with Quality management, Risk management, documentations in a compliant way.
- Should be Hands-on
To learn more about this opportunity please send your CV ASAP in Word format to Brine SA.
Work location: Basel
Duration: till 30.09.2020
Salary: to be discussed
Permit: EU permits
Ref. Nr.: EW2625
BRINE SA has been providing its IT- and SAP specialists for short-, mid- and long-term projects in Switzerland since 1985, with customers primarily active in the following market sectors:
Financial services sector, especially banks and insurance companies
Government and services sectors
BRINE SA is a stable, financially independent, Swiss enterprise with its head office in Zurich. Our services cover the entire IT spectrum, as well as interfaces to the various business sectors, and range from management- and IT-consulting through to software development and project implementation.
IT - Resources
We offer our top consultants, computer Profi's and SAP experts to our customers as external specialists for limited assignments and as well for permanent positions. BRINE SA is especially distinguished by its renowned characteristic strengths:
Short reaction time - rapid selection and supply of consultant's CVs, with skills matched to customer requirements.
Quality - we take quality very seriously, both for internal and external-facing processes, thereby convincing many customers to maintain a long-standing business relationship with BRINE SA
Coaching - BRINE SA coaches and supports its consultants throughout the entire duration of the customer assignment.
BRINE SA is ISO 9001:2008 certified since 2014