QA Compliance Manager Quality Control/Quality Assurance in Pharma, cGM

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Beschreibung

QA Compliance Manager (Quality Control/Quality Assurance in Pharma, cGMPs(German/English)

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.

BRINE SA is currently looking for a Compliance Manager for our Client in Basel.

Job Purpose

  • Coordinates and compiles APRs/PQRs in accordance with GMP requirements and ensures that follow-up activities are defined, carried out and reported

  • Supporting of diverse IT systems, ex DMT, RMT, Agile CCEX, SAP and others in a QA CPL Role

  • Maintains relevant SOPs, supports for GMP training

  • Supports/Leads Self Inspections (as Lead auditor or Co-Auditor) and execution of Health Authority Inspections, Customer Audits and Internal inspections

  • Initiates and leads quality improvement projects

  • Coordinates local implementation of Client Quality Manuals and GOPs

Experience

  • (Technical) University or academic degree in Chemistry, Biology, Pharmacy or equivalent

  • Post graduate diploma in business administration or equivalent

  • Professional experience in Quality Control/Quality Assurance or in the manufacturing of pharmaceutical drug products and Steriles/Biotechnology

  • Profound knowledge of cGMPs

  • Proven track record with FDA, EMEA and other Health Authorities.

  • Strong understanding of risk assessment and risk management fundamentals/tools Minimum requirements

  • Pharma Know-How REQUIRED!

  • Fluent in German and English (spoken and written) REQUIRED!

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

Work location: Stein

Start: June 1st 2018

Duration: until May 31st 2019

Workload: 100%

Salary: Local Market rate according to experience

Permit: EU permits

Ref. Nr.: HS2444

    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

    Start
    1.6.2018
    Dauer
    30.4.2019
    Von
    BRINE SA
    Eingestellt
    09.05.2018
    Projekt-ID:
    1551917
    Vertragsart
    Freiberuflich
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