QA CMO Specialist (packaging and Distribution)

My client is a growing biopharmaceutical company based in the French part of Switzerland looking to expand their quality team. Due to this growth my client is looking for a QA CMO Specialist for packaging and Distribution activities at international level.

Your Responsibilities

  • Be the primary QA contact for products launches in line with regional scope.
  • Ensure implementation of Change Controls within product in scope
  • Support new product submission in and outside of EU for secondary packaging CMO.
  • Ensure implementation and maintenance of Packaging & Shipment Specifications.
  • Ensure secondary packaging validation activities for the introduction of new commercial products and new markets
  • Support and maintain the qualification status of Cold Chain Supply for commercial products.
  • Coordinate and maintain distribution risk assessment for approved shipping lanes.
  • Ensure on time issuance and assessment of storage or distribution related temperature excursions.
  • Ensure implementation of changes at secondary packaging CMO.
  • Execute CMOs and Distribution Partners audits.
  • Review and approve MPRs, Serialization Data and packaging component Artworks and Proofs.
  • Perform batch disposition for finished products and coordinate with QP/RP for final release.
  • Ensure on time issuance, assessment and close out of packaging or distribution related deviations and returns.
  • Coordinate the execution of the Annual Mock Recall exercise for commercial products.
  • Coordinate the collect of data for packaging CMOs and perform the Annual Product Quality Review.
  • Record, assess and reconcile Product Quality Complaints.

Your Profile

  • Bachelor or Master degree in Life Sciences, medical technologies or engineering.
  • Minimum of 5 years work experience in pharmaceutical industry or scientific related, with at least 3 years in a QA department
  • Experience in suppliers, CMO management ideally in packaging
  • English fluency written and spoken

Noemie OLIVA

Noemie OLIVA

Team leader & Recruitment Manager Life Sciences

Morgane CAYUELA

Morgane CAYUELA

Life Sciences Recruitment Specialist

Marine DOLLAT

Marine DOLLAT

Life Sciences Recruitment Specialist

QA CMO Specialist (Packaging and Distribution)

Jul 21, 2021QA CMO Specialist (Packaging and Distribution)Région Lausanne Full Time Permanent Job noliva@axepta.com Life Sciences

Apply For This AD

Maximum file size: 300 MB.

Allowed Type(s): .pdf, .doc, .docx

Maximum file size: 300 MB.

Allowed Type(s): .pdf, .doc, .docx

To revoke my consent or obtain more information, we invite you to contact Axepta SA directly.