5333 Quality Control Specialist Posted Oct 12
Computer Futures - London & S.E(Permanent and Contract) , Luzern, Luzern, Switzerland
 
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My client are looking for a Quality Control Specialist to join their global pharmaceutical company based in Lucerne, Switzerland. This is an interim contract position for 2.5 months.

Job details are listed below.

Position overview

- The Quality Manager (QM) is deputy of the Quality Responsible Person (QRP), the registered contact to the Swiss Health Authorities for quality issues and works together with the QRP to maintain an open and transparent relationship with Swissmedic and the Cantonal Health Authorities.

- The QM supports the implementation of directives issued by the QRP in GMP/GDP matters in the quality interests

- The QM supports the QRP in overseeing the quality systems and processes, in accordance with local and international regulations and internal standards.General Responsibilities

- Responsible to Swissmedic and company management to assure GxP compliance

- Ensuring that all business is conducted in accordance with the Swiss law on Medicinal Products

- Release of commercial products for the Swiss market independent from commercial functions

- Designated point of contact for the processing of product quality complaints (receipt, classification, forwarding to manufacturer, tracking, information to customers, periodical evaluations)

- Designated point of contact for suspected CDT cases (counterfeits/diversion/tampering)

- Assessment of Product Quality Reviews (PQRs) for an assigned product portfolio

- Taking decisions concerning destruction of returns

- Overall responsibilities for GxP activities in the re-labelling/re-packaging of pharmaceuticals

- Performing of internal audits

- Planning and monitoring of general GDP training of employees (initial training, GxP-awareness training)

- Quality oversight/auditing for external service providers (eg external warehouse)

Required expertise and core competencies

Higher education (eg Masters degree) in pharmacy, medicine, biology or a comparable discipline

Familiar with local Swiss, European and international GxP regulations.

Documented experience in GxP regulations

At least 3-5 years of experience in Quality Assurance (GMP/GDP) within the pharmaceutical industry

Excellent analytical and problem solving skills, based on science, data and understanding of regulatory requirements in a complex and evolving environment; ability to apply sound risk management

Fluency in German and English, preferably also French.

SThree are committed to ensuring equal opportunities, fairness of treatment, dignity, work-life balance and the elimination of all forms of discrimination in the workplace for all staff and job applicants. We welcome applications from all suitably qualified persons, regardless of their race, sex, disability, religion/belief, sexual orientation or age.

Employment Type: Contract
Duration: 2.5 months
Other Pay Info: competitive

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