ESO AS&T Expert (Ref.Nr. HS2504)

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.

We are looking for an ESO AS&T EXPERT (EXPERIENCE IN QC, ESPECIALLY ANALYTICAL METHOD VALIDATION AND TRANSFER, ALSO IN PROJECT MANAGEMENT) for one of our customers in Basel.

MUST HAVE

- 5-8 years experience in the pharmaceutical industry
- Min. 5 years experiences in QC, method development, validation or stability testing
- Thorough knowledge of cGMP requirements, cGMP, ICH guidelines, regulatory requirements & risk management
- Experiences in leading project teams, strong track record in project management

MAJOR ACCOUNTABILITIES

Implement and support global AS&T programs in External Supply.

- Defines and implements the business processes and SOPs necessary to maintain a robust Quality System within External Supply affecting the laboratory activities (eg management of changes, maintenance of testing monographs)
- Support Implementation of Guidelines at external partners and suppliers
- Lead programs and initiatives to implement changes and to remediate where required
- Interprets stability data, analyzes trends, and provides scientifically sound conclusions to support assignment and monitoring of product shelf life, storage conditions, packaging and transport categories. Provide corrective actions to address immerging stability issues.
- Support External Suppliers Qualification process
- Support Tech Transfer assessments for analytical method transfers.
- Lead QC aspects of Technical meetings with the External suppliers and establish good working relationships with clear communication and defined actions and goals.
- Support assessments of analytical Change Control records for acceptability. Define studies needed to support the changes.
- Interacts with the External Supplier to guarantee suspect analytical results investigations are managed in agreement with client standards and the right CAPA is implemented.
- Ensure Testing Monographs are state-of-the-art with respect to technique and technology, and in line with registration documentation. Support programs and initiatives to implement changes to, and upgrade Testing Monographs where required
- Support site readiness for Health Authority inspections & participate in audits on request.
- Escalate any issues or instances of instability per the client escalation policy, and initiate any market action that is required.
- Support analytical troubleshooting as needed.

KPIS:

- Number and severity of cGMP issues identified during audits (internal, GCA, HA)
- ESO performance evaluated by the department KQIs

IDEAL BACKGROUND:

- University degree in Pharmacy, Biochemistry, Chemistry, or another related science
- Fluent in speaking/writing in English

To learn more about this opportunity please send your CV ASAP in Word format to BRINE SA.

WORK LOCATION: Basel

START: 02.08.2018 to 31.12.2018

WORKLOAD: 100%

SALARY: to be discussed

LANGUAGE: English - Fluent

REF: HS2504

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

Pharmaceutical industry

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