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Zentiva Hiring in Quality Assurance

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Executive I – QA at Zentiva

About Zentiva:
Zentiva, based in Prague, Czech Republic, is a leading pharmaceutical company specializing in developing, manufacturing, and marketing a wide range of generic and OTC products. With over 4,700 employees across Europe, Zentiva operates three manufacturing sites in Prague, Bucharest, and Ankleshwar.

Position: Executive I – QA

Organization: Zentiva
Qualification: B.Pharm, M.Pharm, MSc, BSc
Experience: Freshers (0 Years)
Salary: 2 to 5 LPA
Location: Ankleshwar, India

Key Responsibilities:

Quality Management/Continuous Improvement:

  • Line clearance and shop floor compliance
  • In-process checks and calibration of IPQC instruments
  • Handling e-tools: SAP Hana, LIMS, eDMS, TrackWise
  • Assisting in investigation, qualification, validation, change control, and deviation systems
  • Preparing and reviewing Annual Product Quality Review
  • Reviewing Batch Manufacturing & Packing Records
  • Coordinating cGMP training activities

Compliance:

  • Ensure adherence to company quality standards and local FDA/MHRA regulations
  • Perform gap analysis and prepare compliance plans
  • Execute compliance plans and review completion activities

Validations & Qualifications:

  • Ensure validated status of equipment, manufacturing, and cleaning processes
  • Review qualification and validation protocols
  • Review validation reports post-execution

Documentation Control:

  • Prepare and review SOPs
  • Control distribution and archival of documents & records
  • Control master documents

Assuring Quality of Products:

  • Ensure SOP compliance
  • Review Batch Manufacturing & Packing Records
  • Implement and review CAPAs from deviations and customer complaints

cGMP Training:

  • Prepare training modules and organize GMP training
  • Execute training programs in coordination with departments

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