QC Regulatory Affairs Specialist (Panchkula)

QC Regulatory Affairs Specialist (Panchkula)

02 Oct
|
UNI-PEX PHARMACEUTICALS
|
Panchkula

02 Oct

UNI-PEX PHARMACEUTICALS

Panchkula

Company Description Uni-Pex Pharmaceuticals Pvt. Ltd. is a WHO-GMP certified generic pharmaceutical manufacturer, within India’s key pharmaceutical manufacturing hub. Established in 1999, the company supplies quality-assured medicines that meet international regulatory standards to distributors, importers, and healthcare providers worldwide. Its portfolio includes 190+ formulations across multiple therapeutic categories, covering tablets, capsules, oral solutions, and nutraceuticals produced under WHO-GMP and ISO 9001:2015 quality systems. With over 25 years of manufacturing and export experience, Uni-Pex maintains an established export network across Africa, Latin America, and Asia/CIS, offering country-specific dossier and product registration support. The organization focuses on consistent quality, reliable supply, and building long-term partnerships while actively expanding into regulated and semi‑regulated markets.
Role Description The QC Regulatory Affairs Specialist is a full time, on-site role based in Panchkula.



This position is responsible for coordinating quality control activities and ensuring that products, documentation, and processes comply with national and international regulatory requirements. Day-to-day tasks include reviewing and maintaining regulatory dossiers, supporting product registrations, and ensuring ongoing compliance with WHO-GMP and other relevant quality standards. The specialist collaborates with quality assurance, production, and documentation teams to address regulatory queries, prepare responses to authorities, and manage change controls. The role also involves monitoring regulatory updates, conducting internal audits related to regulatory compliance, and supporting continuous improvement of quality and regulatory systems.
Qualifications
• Candidates should possess strong skills in Quality Control and Quality Assurance to support compliant manufacturing and testing activities.
• Candidates should possess skills in Quality Manageme

📌 QC Regulatory Affairs Specialist (Panchkula)
🏢 UNI-PEX PHARMACEUTICALS
📍 Panchkula

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