QA/QC Teamleader/Expert

QA/QC TEAMLEADER/EXPERT (ANALYTICAL CHEMICAL AND/OR BIOLOGICAL EXPERTISE, BROAD GMP-AND IT-KNOWLEDGE)

BRINE SA is currently looking for a QA/QC Teamleader/Expert for our Client in the Basel Area

JOB PURPOSE

-

Main contact between QA/QC organisation and customers eg Process Unit, SCM, RegCMC, PhQA, TRD
-

Management of QA/QC processes and procedures, implies product responsibility, validation and qualification, monitoring
-

Provides expertise and supports QA/QC and other customers on technical, analytical and organizational procedures in a Matrix organization
-

Ensures and supports deliveries, HSE, GMP and regulatory compliance for area of responsibility.

MAJOR ACCOUNTABILITIES

-

Maintains and builds contacts with external experts, eg GQO, TRD, RegCMC, SCM, HSE etc. and ensures fast and direct communication channels
-

Provides scientific and technical expertise on QA/QC procedures within ChemOps CH and to other organizations
-

Maintains and adheres to cGMP, SOPs, Rolling Review, CAPA
-

Prepares, participates in and conducts authority inspections and audits
-

Ensure uniform GMP standards through regular exchange with central QA function
-

Initiate revision, validation and improvement of GMP documents eg testing monographs, SOP's, qualification and validation documents
-

Provide input to health authority requests
-

Manage investigations regarding product quality (eg OOS/OOE, deviations, customer complaints)
-

Procures validation support; supports launches
-

Local and global project participation or lead
-

Maintains state-of-the-art knowledge of Health Authority requirements, trends, technologies, processes and systems.
-

University or academic degree in Chemistry, Biology, Pharmacy or equivalent
-

Languages: German and English
-

Experience in chemical/pharmaceutical industry is an advantage
-

General IT-knowledge

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

WORK LOCATION: Basel Area

START: January 2018

DURATION: till 31.12.2018

WORKLOAD: 100%

SALARY: Local Market rate according to experience

PERMIT: EU permits

LANGUAGE: German and English

REF. NR.: HS2335

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 2012