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Specialist, Quality Assurance Logistics (6 Month Maximum Duration) Job

Eingestellt von Celgene

Gesuchte Skills: Support, Design

Projektbeschreibung

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

Prerequisites

- Bachelor or Master in science or medically related field.
- +5 years Quality Control and/or Quality Assurance experience in a pharmac eutical company or other related industry.

Competences

QA Logistics is committed to actively support the International Logistics & Supply Chain to ensure cGDP compliant processes in the distribution of Celgene products.

This position is responsible for quality assurance (QA) involved primarily with the support of the different Quality System tools in place to ensure cGDP compliance in Celgene Logistics and Celgene International II Supply Chain.

The position holder works independently and assists the Sr. Manager QA Logistics. He/she closely works together with International Logistics & Supply Chain, QA Operations (Compliance and Batch Release Office) and other relevant stakeholders (Celgene Europe and other Celgene Affiliates). Furthermore he/she would be in contact with various Contract Service Partners (eg LSPs, Wholesaler and Marketing Partners). Excellent communication skills as well as commitment to Celgene values are required to foster positive relationships both internally and externally.

The Specialist QA Logistics can be assigned special project tasks (Project Work).

Duties and responsibilities
- Is responsible for reporting logistics issues or Deviations/CAPAs, conducting and documenting investigations and following up open actions.
- In charge of tracking and following on a regular basis the distribution issues with International Logistics & Supply Chain
- Supports the qualification process for Distributors/Logistics Service Providers by preparing and updating Technical & Quality Agreements with external Contract Service Partners.
- Supports the Change Control System by initiating Change Control requests and coordinating actions within assigned area of responsibility.
- Assist the processes of return approval, notification to hold batch distribution and product destruction approval in collaboration with International Logistics & Supply Chain (eg traceability in Oracle).
- Contributes to the maintenance of the Celgene Logistics Quality Management System (QMS) by writing, reviewing and by making recommendations for revision of QMM documents (SOPs, Policies, Working Practices, etc).
- Participates in internal GDP-audits within Celgene Logistics and/or gives support or lead external audits. Provides written audit reports or a list of observations and follows up open actions.
- Performs Vendor Annual reviews.
- Follow up on the training status for Celgene Logistics.
- Performs GDP trainings on regular basis to personnel of Celgene Logistics and other Celgene entities (Celgene Europe, Celgene Ltd, etc).
- Contributes to the APR/PQR report by compiling information pertaining to product distribution.
- Prepares trending of Deviations/CAPA and Quality compliance performance (KPI) for Logistics CSPs.
- Responsible in the improvement of existing processes and the development of new processes or sub-processes related to the QMS.
- Communicates as appropriate and in agreement with Celgene's values to foster positive relationships both internally and externally.
- The position holder is foreseen to develop into the role of deputy for the Sr. Manager QA Logistics as appropriate.
- Supports to projects involving Celgene Logistics from QA side (EUNICE, launch of new products, new countries etc ).
- Provides QA Support as appropriate to Celgene International II organization to ensure GDP Standards are met
- Support GDP cross-functional projects such as validations/qualifications (specially execution of transport validation activities)
- Supports risk Assessments projects within supply chain area.
- Maintains Logistics Issues database and coordinates Monthly Logistics Issues meeting.
- Supports design and execution of mock recall exercise.

QUALIFICATIONS
Skills and knowledge required

At least 5 years of experience in Quality Control and/or Quality Assurance in a pharmaceutical company or other related industry, preferably in Logistics Quality Assurance.
BS, preferably MS, in science or related field.
Thorough understanding of cGMPs, GDP and EU as well as FDA regulatory requirements.
Excellent interpersonal, collaborative and organizational skills.
Works independently, yet effectively in a team environment.
Ability to focus attention to details.
Excellent written & oral communication skills.
Excellent investigational and QA problem solving skills.
Knowledge of most common office software (Microsoft Office).

*MONEU
*LI-NS1

REQ ID:
PRIMARY LOCATION: Switzerland-Neuchâtel-BOUDRY
JOB:Quality Assurance
ORGANIZATION:Celgene International SaRL
SCHEDULE:Limited Term
SHIFT:Standard
EMPLOYEE STATUS:Individual Contributor
JOB TYPE:Full-time
JOB LEVEL:Day Job
TRAVEL:No
JOB POSTING:2015-11-27

Projektdetails

  • Einsatzort:

    Boudry, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Celgene