In this role, you will ensure GMP compliance across sterile manufacturing operations while acting as a key quality partner to operational teams. You will oversee quality processes, support investigations, and contribute to continuous improvement initiatives. The position combines hands-on QA activities with cross-functional collaboration and project involvement.

Start Date: ASAP

Duration: approx. 8 Months

Place of Work: Stein (AG)

Key Responsibilities

  • Act as the primary QA contact for assigned activities and projects
  • Prepare, review, and approve quality documents such as SOPs, risk assessments, work instructions, and cleaning documentation
  • Coordinate and approve quality records including deviations, CAPAs, change controls, as well as qualification and validation documentation
  • Provide QA oversight for manufacturing operations to ensure compliance with GMP requirements
  • Support investigations by contributing to root cause analysis, impact assessments, and implementation of corrective actions
  • Collaborate with cross-functional teams on operational and growth-related projects in line with cGMP standards
  • Drive and support continuous improvement and lean initiatives within quality systems
  • Monitor project timelines and ensure transparent communication of progress and status
  • Collaborate with external partners and customers to define release strategies aligned with quality standards
  • Provide expert guidance on GMP compliance across all relevant activities
  • Define, track, and report quality KPIs where required
  • Support and maintain the quality oversight framework within manufacturing operations
  • Participate in audits and inspections as required and contribute to audit readiness
  • Guide and support team members and contribute to a collaborative and high-performance culture
  • Support onboarding of new team members and act as deputy for leadership roles when needed

Candidate Profile 

  • Academic degree in Chemistry, Biology, Pharmacy, or a related field
  • Several years of experience in Quality Assurance or Quality Control within the pharmaceutical manufacturing environment
  • Strong understanding of GMP and regulatory requirements in manufacturing operations
  • Experience in handling quality systems such as deviations, CAPAs, and change controls
  • Structured and solution-oriented mindset with strong problem-solving skills
  • Ability to prioritize tasks effectively and manage multiple responsibilities
  • Strong collaboration skills and customer-oriented approach
  • Excellent communication skills in English, German is a plus
  • Experience working in cross-functional and international environments

 

 

 

 

Job ID 18863