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Simtra BioPharma Solutions
last mo.

Specialist QA Client Communication(m/w/x)

Halle (Saale)
Full-timeOn-siteExperienced

Description

In this role, you will be the key QA representative for clinical and commercial projects, ensuring compliance and quality by managing client relationships, reviewing documentation, and supporting audits and inspections.

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Requirements

  • •Completed studies in Pharmacy, Chemistry, Biology, Technology, or a related field
  • •3+ years of experience in the Pharmaceutical or Biotech industry
  • •Experience in Quality Assurance and Aseptic Manufacturing
  • •Strong knowledge of cGMP guidelines and microbiology
  • •Strong ability to deliver training and feedback
  • •Decisive and solution-oriented mindset
  • •Excellent communication skills in German and English

Education

Bachelor's degree

Work Experience

3 years

Tasks

  • •Act as the QA representative for clinical and commercial transfer projects
  • •Serve as the main QA contact for clinical and commercial clients
  • •Manage the QA relationship with clients
  • •Oversee QMS activities between SMEs and clients
  • •Translate client needs into QA requirements
  • •Provide feedback on QA requirements
  • •Review product-specific SOPs and documentation
  • •Review validation documents
  • •Monitor Stage-Gate Reviews
  • •Ensure compliance with Simtra and cGMP standards
  • •Accompany special manufacturing steps
  • •Support client visits in the manufacturing area
  • •Explain Simtra quality standards and processes with details from SMEs
  • •Advocate for Simtra processes to enhance new manufacturing quality
  • •Review specific NCRs
  • •Support process improvements in QA and Pharma Production
  • •Assist with client audits and MOH inspections for client products
  • •Review Change Control and communicate with clients

Languages

German – Business Fluent

English – Business Fluent

Benefits

Bonuses & Incentives

  • •13th month's salary

Retirement Plans

  • •Company pension plan

Healthcare & Fitness

  • •Additional nursing care insurance
  • •Free company sports

Free or Subsidized Food

  • •Attractive cafeteria subsidies

More Vacation Days

  • •30 days of vacation

Company Bike

  • •Job bike leasing

Corporate Discounts

  • •Exclusive employee discounts

Parking & Commuter Benefits

  • •Free employee parking

Additional Allowances

  • •Financial support for relocation
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