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ID: POS08484

Quality Control Specialist (m/f/d)

Pharma & Biotech
Asap
12 months
Lucerne, Switzerland
Contractor
K-Recruiting Schweiz AG
Contact:

Cristina Croppi

+49 89 1890998-625

cristina.croppi@k-recruiting.com

Quality Control Specialist (M/F/D)

 

Tasks:

  • Review and approve Master batch records and ensure conformance to all applicable policies/procedure and compliance with all governing regulations.

  • Manage routine and complex deviations

  • Support process and analytical change requests.

  • Assist the maintenance of retention samples, ship reagents and samples to support licensure and foreign registration; responsible for shipment under quarantine.

  • Support routine process validation; review and approve validation reports/tech transfer

  • Prepare pre-PAI assessments; support document requests for regulatory filings and post approval changes.

  • Regular site visits to build relationships and monitor efforts to improve the external manufacturer’s quality and reliability through ongoing oversight and formal communication programs and forums.

  • Previous experience in the pharmaceutical industry with thorough knowledge of Quality Systems, Quality Assurance, and Quality Control including global GMP Quality Systems

 

Qualification:

  • Solves complex problems; takes a new perspective using existing solutions.

  • Works independently, receives minimal guidance.

  • Acts as a resource for colleagues with less experience within own discipline; can provide minimal guidance on issue resolution and act as SME.

  • May act as a team or project lead and lead work of others as required; promotes teamwork and open discussion of issues, coaches and guides others.

  • Explains difficult issues and works to build alignment around a complex situation.

  • Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership skills.

  • Strong knowledge of External Manufacturing management, supply chain, and operations.

  • Fluent in English, German language skills are of advantage

  • Nice to have:

  • Direct experience with managing external partners.

  • Experience with manufacturing operations and/or analytical expertise associated with

  • biologics and/or vaccines.

  • Previous experience with regulatory communications such as Biologics License Applications

  • (BLAs), New Drug Applications (NDAs)

  • Degree in Science, Engineering or any relevant technical discipline (BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering, or equivalent preferred).

  • Previous experience in the pharmaceutical industry with thorough knowledge of Quality Systems, Quality Assurance, and Quality Control including global GMP Quality Systems and regulatory requirements preferred

 

Requirements: 

Start: 01.09.2025

Duration: 12 months

Capacity: 5 days per week

Location: Lucerne, Switzerland

 

Have we peaked your interest? Let's go
Contact
Cristina Croppi
+49 89 1890998-625
cristina.croppi@k-recruiting.com