HCLTech – Hungary

Senior QA Lead

HCLTech – Hungary  •  Onsite  •  4 hours ago
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Job Description

Job Summary

The Analytical Scientific Integrator serves as the Single Point of Contact (SPoC) for all analytical development (AD)–related activities supporting commercial and marketed products across the product lifecycle. This role provides strategic, scientific, and regulatory leadership for analytical aspects of post-approval change management, specification strategy, and lifecycle management of APIs, intermediates, starting materials, and drug products.

The position is accountable for translating project and lifecycle strategies into executable analytical plans, ensuring compliance with global regulatory expectations, compendial requirements, and internal quality standards. The role acts as an analytical expert and specification owner for assigned portfolios of established products and partners closely with cross‑functional technical teams, external manufacturing, and regulatory stakeholders.

Key Responsibilities

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Skill Requirements

Strong expertise in analytical techniques (e.g., chromatography, spectroscopy, dissolution, compendial testing). Deep understanding of ICH guidelines (Q2, Q6, Q8, Q9, Q10) and global pharmacopeial requirements (USP, EP, JP). Risk-based approach to control strategy and specification justification. Solid knowledge of GMP, data integrity, and regulatory

Other Requirements

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HCLTech – Hungary

About HCLTech – Hungary

HCLTech is a global technology company, home to more than 226,600 people across 60 countries, delivering industry-leading capabilities centered around digital, engineering, cloud and AI, powered by a broad portfolio of technology services and products. We work with clients across all major verticals, providing industry solutions for Financial Services, Manufacturing, Life Sciences and Healthcare, Technology and Services, Telecom and Media, Retail and CPG, and Public Services. Consolidated revenues as of 12 months ending September 2025 totaled $14.2 billion. To learn how we can supercharge progress for you, visit hcltech.com.

Industry
IT & Software
Company Size
51-200 employees
Headquarters
Budapest, HU
Year Founded
2006
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