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Senior QA Coordinator - 100%

Posted on Sep 26, 2019 by Coopers Group GmbH

Basel, Switzerland
Health Care
Immediate Start
Annual Salary
Contract/Project

For our Pharma client in Basel we are looking for a Senior QA Operations Coordinator

Key tasks and responsibilities:

  • Ensure and perform QA operational activities, such as review of manufacturing batch record, release documentation associated with Drug Product and Drug Substance
  • Provide Batch record review and BoM (Bill of Materials) approval related to external manufacturing of large molecule products ensuring reliable and safe drug supply to patients and compliance to regulatory and cGMP requirements
  • Prepare documents relevant to batch processing/shipping and market supply, eg CoA, CoC
  • Manage and track timely compilation and review of APR/PQR as well as trending analysis of data (eg QC, stability) provided by the CMO (Contract Manufacturing Organization)
  • Provides tracking and trending analysis/KPIs relevant to business processes
  • Perform CMO site visits for batch record review and Person-in-Plant activities
  • Act as key user and/or Local Change Manager (LCM) and/or Q-Unit approver for BASICs
  • Coordinate change management activities, related documentation and propose requirements for technology transfers, process validation, cleaning validation, analytical methods validations, GDP, other CMC studies
  • Review and approve changes and reports (eg stability, qualification, validation)
  • Write and reviews SOPs, provide QA input, review and approval of SOPs, TRDs (Technical Registration Documents) to assure regulatory compliance
  • Maintain awareness of current GMP trends and supports continuous improvement within the Quality Unit
  • Provides support for regulatory agency inspections and requests

Must haves:

  • Master Degree in (bio)-chemistry, pharmacy or biotechnology or similar education
  • Minimum 3 years of experience in the field of quality assurance/quality control/validation in the pharmaceutical or related industries
  • Advanced knowledge and experience in (bio)-pharmaceutical subject matter areas incl. manufacturing of bulk, intermediates and final containers, discrepancy management, product inspection and labeling as well as contract manufacturing
  • Broad experience and knowledge in the field of cGMP, QA/QC and regulatory compliance (US and other international agencies)
  • Ability to propose and streamline business processes to maximize efficiencies, to resolve discrepancies and trending issues and able to adapt to changes in the organizational structure
  • Proficiency in Microsoft Office (Word/Excel/Outlook) applications
  • Strong interpersonla skills
  • Excellent communication skills, good presentation and influencing skills
  • Proficiency in English, both written and spoken; Knowledge of German language would be an asset

Start date: ASAP
Duration: 6 months
Location: Basel

Reference: 762099987

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