Associate Specialist, QA Operations

Celgene — Couvet
15.10.2019 | Employee | 100%

Associate Specialist, QA Operations

Req #: 1903694
Location: Couvet, Neuchatel, Switzerland
Job Category: Quality
Work Location: Rue du Pr-Jorat 14 2108
Organization: Quality Operations
Shift: 2nd Shift Standard8_CHE
Employee Status: Full-time

Temporary Assignment
SHIFT 2X8

QA Operations Team is committed to actively support the Celgene International II site and other departments to ensure cGMP compliant processes on the Couvet site. This position is responsible for quality assurance (QA) involved primarily with the review of bulk or packaged commercial drug products and maintaining working relationships with QA departments at contract facilities. The position will support QA activities (archiving, deviation, CAPA, OOS, change control,...) on the Celgene international II Srl manufacturing site of Couvet. As a member of Quality Operations team, this position will be expected to be reliable source of information and interpretation of quality and cGMP compliance requirements. Furthermore, you will be responsible to identify and handle packaging, warehouse, or bulk/QC and cGMP compliance related issues. You may also be asked to support the QA team of Celgene International Srl in Boudry. Additional tasks are quality metrics, manufacturing investigation for complaint, release of raw materials for production, risk assessments, aswell as the support of health authorities' inspections and corporate
audits.

This position will be working closely with the QA Operations management to identify and handle process quality and cGMP compliance related issues, ensure lean release of finished product or bulk product, raw materials for production, as well as to contribute to process improvement in his/her scope of activity.

Skills/Knowledge Required

  • At least 1-2 years of experience in Quality Control and/or Quality Assurance in a pharmaceutical company or other related industry.
  • BS in science or medically related field.
  • Good understanding of cGMPs and Swiss, EU, and FDA regulatory requirements.
  • Good understanding of Solid Oral Dosage from packaging, warehousing, or bulk and QC processes.
  • Excellent interpersonal, collaborative and organizational skills.
  • Works independently, yet effectively in a team environment.
  • Strong written & oral communication skills in both French and English.
  • Very good investigational and QA problem-solving skills, has a keen eye for Quality, makes proposals and facilitate decision when escalation is needed.
  • Ability to focus attention to details and to handle multiple tasks while working against pressures of deadlines.
  • Collaborative, organisational
  • Sense of responsibility, reliability, team spirit, initiative and service.
  • Knowledge of most common office software.
As the QA Operations Associate Specialist, you'll support that goal by....
  • Supports the design of Master Batch Records for bulk or finished pharmaceutical drug product.
  • Is responsible for the review "on the floor" of executed batch records of bulk or finished product.
  • Ensures ExBRs and documents into the shared drive, and folders.
  • Ensure archiving of the documentation for compliance to GMP as appropriate.
  • Writes new, revises and makes recommendations for SOP and quality documents for Quality department and supported departments of Couvet manufacturing site.
  • Handles deviations, CAPA and change control related to Celgene international II packaging and warehouse or bulk and QC issues as assigned and to ensure the execution / follow up of escalation processes up to both Celgene international and the global level.
  • Supports the requests either from the stakeholders as appropriate.
  • Handles qualification and validation documentation for QA review of relevant documents/reports (DQ, IQ, OQ, PQ, Cleaning Validation, Process Validation) and supports execution.
  • Support during Authorities inspections audits and visits to external manufacturers/suppliers by participating when requested.
  • Handles complaints and executes investigations as assigned.
  • Represents QA within department and cross functional project teams according to assignments.
  • Participate to recommendations for continuous improvements in Quality systems as required.
  • Contributes of regular reporting of quality processes metrics.
  • Ensures that all regulations concerning product security and all established working methods are respected within the area of responsibility.
About Us

COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE

At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.

"At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients."

There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.

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