QA PL Drug Product

vor 1 Woche


Visp, Schweiz Real Staffing Vollzeit

Sales Consultant at Real Staffing - SThree

QA PL Drug Product Specialist

Duration: 8 months initial

Tasks:

  • Supervise compliance and customer Quality Agreement (QAA) activities for Drug Product Visp.
  • Establish and negotiate QAAs with Drug Product Services (DPS) and Drug Substance (DS) sites.
  • Address QA-related questions, topics, and complaints from customers.
  • Manage changes, deviations, technical complaints, and out-of-specification results.
  • Represent QA in cross-functional teams and customer meetings during technical transfers.
  • Act as QA contact for specific projects and manage routine follow-ups with customers.
  • Support and approve project/product-specific risk assessments and regulatory gap assessments.
  • Review and release product-specific documentation.
  • Collaborate with QC-Project Leader (QC-PL) and MSAT for new product introductions (NPI).
  • Assess, review, and approve quality records, including deviations, change control, CAPAs, and investigations.
  • Author, review, and approve GMP-relevant documents and SOPs.
  • Support continuous improvement programs for the Quality Management System.

Requirements:

  • 5-10 years of experience in pharmaceutical or biotechnology industries.
  • Strong QA and Quality Management Systems knowledge.
  • Experience in establishing and negotiating QAAs.
  • Ability to manage customer interactions and handle complaints.
  • Understanding of risk assessments and regulatory requirements.
  • Excellent communication and teamwork skills.
  • Experience with GMP-relevant documents and SOPs.
  • Ability to support continuous improvement programs.
  • Fluency in English; proficiency in German is a plus.
  • Proficiency in handling deviations, change control, CAPAs, and investigations.
  • Collaboration with QC-Project Leaders and MSAT for new product introductions.
  • Valid Swiss work permit or EU-Citizenship.

Seniority Level: Entry level

Employment Type: Full-time

Job Function: Quality Assurance

Industries: Pharmaceutical Manufacturing

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