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Simtra BioPharma Solutions

Sterile injectable drug manufacturing

Lead QA Shopfloor Oversight

Validation, Compliance & Quality SystemsConfirmed live in the last 24 hours
Full-timeHalle, GermanyIn-person

About the Job

Requirements

  • A completed degree in a natural science discipline, or comparable pharmaceutical or scientific training with relevant professional experience, such as pharmaceutical technician training with a master craftsman qualification, state-certified technician qualification in pharmaceutical technology, chemical technology, or biotechnology, or a comparable qualification.
  • At least 3 years of experience in the pharmaceutical industry, preferably in GMP production or quality assurance for parenteral products.
  • Several years of experience and good knowledge in aseptic manufacturing and pharmaceutical production or quality assurance.
  • Very good knowledge of international current Good Manufacturing Practice regulations, data integrity, and technological and process requirements for pharmaceutical manufacturing.
  • Experience in professional leadership, shift coordination, or work allocation, with strong coordination and prioritization skills in an operational shift environment.
  • Confident use of Microsoft Office and electronic quality management systems such as Veeva or TrackWise, plus basic knowledge of enterprise resource planning systems.
  • Very good spoken and written German and English.

Responsibilities

  • Provide professional leadership and operational coordination for the QA Shopfloor Oversight team, including shift and task planning.
  • Direct QA shop-floor oversight across assigned production and support areas.
  • Oversee weighing and compounding processes, aseptic filling, visual inspection, line clearance, cleaning, and product segregation.
  • Ensure manufacturing processes and documentation comply with current Good Manufacturing Practice, standard operating procedures, quality standards, and ALCOA+ data integrity principles.
  • Review relevant manufacturing and GMP documentation, and oversee cleanrooms, production equipment, and manufacturing activities during operation and shutdown.
  • Guide, onboard, qualify, and develop technicians, ensuring the required GMP, quality, and process understanding.
  • Assess quality-related issues, make QA decisions, and escalate critical matters affecting product quality.
  • Coordinate deviations, corrective and preventive actions, and change controls, and track immediate and follow-up actions.
  • Ensure audit readiness; support regulatory authority, customer, and internal audits; and analyze and report quality and performance metrics, risks, and improvement measures.
  • Work shifts and weekends as required.

Desired Qualifications

  • Experience in GMP production or quality assurance for parenteral products is preferred.

About the Company

Simtra BioPharma Solutions

Sterile injectable drug manufacturing

Simtra BioPharma Solutions is a contract development and manufacturing organization specializing in sterile injectable medicines. It supports pharmaceutical and biotechnology companies with formulation, process development, clinical and commercial manufacturing, filling, packaging and related technical services. Facilities and teams operate under regulated quality systems suited to complex parenteral products. Simtra is a business-to-business manufacturing partner rather than a consumer drug brand, helping sponsors move therapies from development into reliable supply through dedicated production expertise and capacity.

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