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Executive - Validation & Qualification QA

Intas
Ahmedabad
3-8 Years
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Job Description

Role & responsibilities

  • Develop, execute, and document qualification protocols (DQ/IQ/OQ/PQ) for equipment, utilities, and facilities.
  • Collaborate with Engineering, Production, QA, Or other Cross functional teams to coordinate qualification activities.
  • Maintain qualification documentation, including risk/impact assessments and change-control records.
  • Ensure compliance with USFDA, MHRA, WHOGMP, and ICH Q9/Q10 standards.
  • Support internal and external audits and inspections focused on qualification.
  • Diagnose deviations in qualification processes and initiate CAPAs.
  • Manage and update the Qualification Master Plan and requalification schedules.
  • Specialize in injectable product qualification (media fill, aseptic simulation, smoke studies).
  • Oversee qualification of systems such as water, steam, HVAC, filling/sealing machines, autoclaves, isolators, washing tunnels/DHS units, and more

Preferred candidate profile

Deep knowledge of qualification and validation best practices (equipment, utilities, facilities) and Hands-on experience with media fill/aseptic simulation, smoke studies, and utilities (water, steam, HVAC).

  • Proficient in URS/DQ/IQ/OQ/PQ processes for various equipment (vial/ampoule washers, filling/sealing units, autoclaves, isolators).
  • Strong understanding of equipment qualification, utility validation, and cleanroom classification.
  • Familiarity with cGMP, data integrity (ALCOA+), and GxP documentation standards.
  • Competent in creating/reviewing technical documentation and qualification protocols in line with regulatory requirements.
  • Excellent analytical and problem-solving skills, with a methodical attention to detail.
  • Proven ability to collaborate cross-functionally and interface confidently during audits and inspections.

More Info

Job Type:
Permanent Job
Industry:
Pharmaceutical
Role:
Other Roles
Function:
Others
Employment Type:
Full time
Open to candidates from:
Indian

About Company

Intas

Intas is one of the leading multinational pharmaceutical formulation development, manufacturing, and marketing organization in the world. It has been growing at 19% CAGR and crossed the $2.5 billion mark in the past financial year. The company has set up a network of subsidiaries, under the name Accord Healthcare in the EU, US, Canada, SA, Australia, APAC as well as CIS & MENA regions. Intas is present in 85+ countries, with more than 70% of its revenue coming from global business.

Currently ranked 6th in the Indian pharmaceutical market, it’s the largest privately owned Indian generic pharma company. Intas has established leadership in key therapeutic segments like CNS, Cardio, Diabeto, Gastro, Urology, Oncology & Animal Health in India. We are among the top 10 generic players in the highly regulated markets of EU, US & UK.

Intas operates 17 advanced formulations, R&D, and distribution facilities, of which 10 are in India and the rest in the UK, Mexico & Greece with the help of our 23,000+ Human Capital. Between them, the facilities are accredited by global regulators such as USFDA, EMA, MHRA, TGA, and others. The company invests 6-7% of its revenues in R&D and has over 10,000 product registrations worldwide with a strategic pipeline of 300+ high-value FTF/FTM, Biosimilars, and NDDS products.

Intas' highly advanced EU-GMP Certified Biopharma division is fueled by a mission to provide affordable “Biosimilars for Billions” across niche segments such as oncology, auto-immune, ophthalmology, nephrology, rheumatology, and hormone-based therapies.

The Plasma Fractionation Unit of Intas Pharmaceuticals is a pioneer in manufacturing plasma-derived therapeutics. It houses a full-fledged R&D lab and a state-of-the-art WHO-GMP-certified manufacturing facility complemented with a GLP-compliant QC lab.

Our values of Innovation, Customer Delight, Ownership & Collaboration, Performance Focus & Care for Society are the driving forces toward excellence.

Job ID: 121673105

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Last Updated: 05-11-2025 07:28:35 AM
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