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Zentiva

Produces branded generic pharmaceuticals in Europe

Assistant Manager Quality Control - Pharmaceuticals

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

About the Job

Requirements

  • Postgraduate education in Science (Organic or Analytical Chemistry), or B.Pharm/M.Pharm.
  • Eight to ten years of experience in a chemical and instrumental testing laboratory, with exposure to Good Manufacturing Practices and Good Laboratory Practices.
  • Analytical ability.
  • Troubleshooting ability.
  • Coordination ability.
  • Communication ability.
  • Problem-solving ability.

Responsibilities

  • Implement pharmaceutical quality-control activities at Ankleshwar in compliance with regulatory and global quality directives and health, safety, and environmental guidelines, using resources effectively to ensure consistent product quality and meet customer requirements while adhering to organizational values and ethics.
  • Perform and organize timely analyses of raw materials, bulk products, intermediates, finished goods, and other pharmaceutical samples.
  • Perform and organize analyses of market complaints, stability samples, process-validation samples, and cleaning-validation samples.
  • Perform and organize calibration and maintenance of laboratory equipment, and assist with laboratory equipment qualification.
  • Review pharmacopeias to prepare specifications.
  • Prepare standard operating procedures, formats, specifications, analytical test records, and other documents.
  • Manage reference standards, working standards, laboratory chemicals, and reagents.
  • Manage laboratory instruments, including spares and maintenance.
  • Manage control samples and related records.
  • Approve or reject raw materials, packaging materials, in-process materials, bulk finished products, and bulk medical devices.
  • Investigate out-of-specification results, retesting, and review of analysis records.
  • Maintain and review laboratory raw data and logbooks related to testing activities.
  • Review chromatographic data.
  • Prepare protocols and reports for analytical method validation and cleaning validation, and perform or organize validation exercises according to the protocols.
  • Support testing of process-validation and verification samples.
  • Identify and plan laboratory consumables requirements and monitor stocks of chemicals, glassware, and printed materials.
  • Coordinate analytical activities with production and warehouse teams.
  • Ensure compliance with health, safety, and environmental requirements for quality-control operations.
  • Identify and correct unsafe conditions or behaviors and promptly report other potentially hazardous situations.
  • Carry out other assignments or projects as instructed by the department head to meet organizational objectives and priorities.
  • Train subordinate staff in laboratory-related work.

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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