Quality Site Manager

Basel-Stadt  ‐ Vor Ort
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Beschreibung

Quality Site Manager

Randstad Professionals is looking for a Senior Quality Site Manager for our client in Basel. This role is 80% wherein you will be 2 days in Basel & 2 days in Berne. This is a 12 months contract and the candidate should be able to travel 25% of the time within Europe.

Key Areas and responsibilities:

  • Single point of contact (SPoC) for Quality and Compliance Issues between CMO and the client
  • Negotiate and maintain Quality Agreements between the client and CMO
  • Maintain inspection & Audit readiness
  • Participate in CMO regulatory inspections and the client Compliance audits, if needed
  • Support site selection activities
  • Lead GMP Commissioning efforts in line with the CMO life cycle
  • Technical transfers/Quality Lead
  • Manage CMO with regard to compliance and product quality
  • Participate in Decommissioning efforts
  • Represent Quality in Governance Committee meetings
  • Support product complaint investigations
  • Perform quality risk assessments, develop mitigation plan and follow-up on implementation
  • Lead quality/process improvements with the CMO
  • Ensure timely follow-up on CAPA at the CMO
  • Monitor and report quality performance of the CMO
  • Quality support of new development and design projects as applicable
  • Provide on-site support during production and issue resolution by fostering effective interdepartmental and cross functional partnership
  • Communicate new and updated regulatory and applicable client Standards to CMO, evaluate systems in place
  • Escalate gaps of audit responsiveness, CAPA implementation, deviation reporting and management, investigation closure, HSE issues and change implementation with regard to quality and time
  • Review of quality and compliance related documents such as but not limited to Master Batch Records, Deviation Reports
  • Initiate/approve analytical transfer protocols/reports, process validation protocol/reports and change requests
  • Create, review and evaluate CMO-related sections of the APR/PQR coordinate stability studies and sampling plans for release/stability with external and internal partners
  • Coordinate and facilitate CMC variations and dossier updates as applicable between the client's technical regulatory and CMO
  • Coordinate and manage CMO related changes
  • Provide input to personal performance goals and departmental objectives
  • The incumbent is responsible for personal training and continuing professional development.

Required Skills:

  • Minimum BS degree. MS, PhD in chemistry, biology, pharmacy, engineering or other life science preferred.
  • Experience in execution of quality operations and processes in the pharmaceutical industry required
  • Experience in drug product manufacturing is preferred
  • Strong analytical and creative problem solving skills to address a broad range of complex problems to support quality decisions; track record of problem solving in product quality
  • Strong quality orientation with knowledge of cGMPs (FDA; EMA, Swiss Medic, Anvisa, JP)
  • Regulatory guidelines and validation practices; track record of successful regulatory inspection preparation
  • Effective communicator at all levels; excellent written, oral and interpersonal communication and presentation skills (English must, German or French beneficial)
  • Ability to travel ca. 25% of the time, mainly in Europe

Good to know you!

Please note that only candidates who are a close match will be contacted regarding this role; non EU/EFTA Citizens cannot be considered.

Start
ab sofort
Dauer
12 months
Von
Randstad (Schweiz) AG
Eingestellt
20.01.2015
Projekt-ID:
837164
Vertragsart
Freiberuflich
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