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Zentiva

Produces branded generic pharmaceuticals in Europe

Validation Specialist

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeBucharest, RomaniaNo salary listedIn-person

About the Job

Requirements

  • A university degree in chemistry, biochemistry, biology, pharmacy, chemical engineering, or medicine.
  • Advanced proficiency in English.
  • Proficiency using a computer, including Microsoft Word, Excel, and PowerPoint.
  • Thorough knowledge of applicable guidelines and legislation, including Good Manufacturing Practice Annex 15 on Qualification and Validation and Annex 11 on Computerized Systems.
  • General knowledge of product manufacturing and of equipment used in manufacturing and its control.
  • At least five years of continuous work in a production, quality control, or quality assurance department at a research or pharmaceutical manufacturing facility; ten years is preferred.
  • Preferred experience in a similar management position at a company manufacturing human medicines.
  • Ability to analyze, interpret, and synthesize information and data; organize and plan; think independently; make decisions and solve problems; communicate and build relationships internally and externally; and maintain attention to detail, rigor, and objectivity.

Responsibilities

  • Manage, coordinate, continuously monitor, and improve validation and qualification processes, including cleaning validation, manufacturing equipment qualification, quality control, computerized systems, critical utilities, workspaces, and transport validation.
  • Prepare, review, or approve documentation affecting the area, including the Validation Master Plan and qualification and validation protocols and reports, with reference to applicable good manufacturing and documentation practices, laws, regulations, and company standards, policies, and procedures.
  • Prepare, verify, modify, and approve documents and implement actions related to the work of the Validation and Qualification team in accordance with applicable good manufacturing and documentation practices, laws, regulations, and company standards, policies, and procedures.
  • Assess the local impact of global Quality Management System documents and propose local improvements to align with group requirements.
  • Propose changes to, withdrawal of, or development of quality documents in accordance with applicable legislation and internal and international regulations.
  • Manage and retain working documents and preserve the information contained in them.
  • Keep the database of Validation and Qualification Protocols and Reports current and distribute them under controlled conditions.
  • Implement a clear and coherent Validation Plan for organizing and managing the company's related activities.
  • Participate in qualification of manufacturing, analytical-control, and microbiological-control equipment, and in validation of cleaning, computerized systems, and transport.
  • Develop, verify, and, where appropriate, approve general documents in the area of qualification and validation, including procedures, instructions, the Validation Master Plan, protocols, reports, and other relevant documents.

Desired Qualifications

  • Ten years of relevant continuous work experience is preferred.
  • Experience in a similar management position at a company manufacturing human medicines is preferred.

About the Company

Zentiva

Produces branded generic pharmaceuticals in Europe

Zentiva makes branded generic medicines for European markets. Its products are off-patent drugs reformulated and marketed under Zentiva’s brands, delivering the same active ingredients and dosage as original medicines at lower prices. It differentiates itself through a long history as an independent platform under private equity, with a growth strategy built on acquiring brands to expand its European footprint. The goal is to become a leading European branded generics platform and improve access to affordable medicines across its markets.

Company size
1,001-5,000
Company stage
IPO
Headquarters
Prague, Czechia
Founded
2003

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