Officer - QA

Job Description:

Intas Pharmaceuticals is seeking an Officer – QA to join their dynamic team and support quality assurance functions related to qualification and validation activities. The involves ensuring compliance with regulatory standards, maintaining documentation accuracy, and contributing to overall quality systems within the organization.

Roles & Responsibilities:

• Prepare and review media fill documentation and qualification summaries
• Monitor and track all qualification and validation activities to ensure timely completion
• Develop, execute, and review protocols and reports for validation and qualification processes
• Evaluate technical documents received from vendors including DQ, IQ, OQ, PQ, and FAT reports
• Coordinate with production and cross-functional departments for smooth execution of validation activities
• Compile and review validation and qualification reports within defined timelines
• Verify calibration and equipment-related documents to ensure accuracy and compliance
• Perform and support Factory Acceptance Testing (FAT) activities
• Liaise with external agencies for execution of qualification and validation tasks when required
• entify deviations through document review and process observation and ensure proper documentation
• Prepare and maintain annual re-qualification and validation schedules
• Update Validation Master Plan (VMP) and related SOPs as per regulatory and operational requirements

Intas Pharmaceuticals Ltd. is a leading vertically integrated global pharmaceutical company engaged in formulation development, manufacturing, and marketing. The company is committed to addressing unmet medical and societal needs through a strong and comprehensive pharmaceutical value chain.

It operates globally through its subsidiaries under the brand
Accord Healthcare, enabling a strong presence in international markets.

Global Presence & Growth

• Present in 85+ countries worldwide
• Strong presence in North America, Europe, Latin America, Asia-Pacific, CIS & MENA regions
• Over 70% revenue from global markets
• Achieved ~19% CAGR growth
• Crossed $2.5 billion revenue milestone
• Ranked 6th in the Indian pharmaceutical market
• Among the top 10 generic players in regulated markets like the EU, US & UK

Infrastructure & Workforce

• 17 advanced facilities (manufacturing, R&D, distribution)
  • 10 in India
  • Others in the UK, Mexico & Greece
• Facilities approved by global regulators such as:
  • USFDA, EMA, MHRA, TGA, etc.
• Strong workforce of 23,000+ employees

Research & Development (R&D)

• Invests 6–7% of revenue in R&D
• 10,000+ product registrations worldwide
• Pipeline of 300+ high-value products including:
  • Biosimilars
  • New Drug Delivery Systems (NDDS)
  • First-to-File / First-to-Market products

Key Therapeutic Areas

• CNS (Central Nervous System)
• Cardiology
• Diabetology
• Gastroenterology
• Urology
• Oncology
• Animal Health

Specialized Capabilities

• Advanced Biopharma division focused on “Biosimilars for Billions”
• Expertise in niche therapies:
  • Oncology
  • Auto-immune diseases
  • Ophthalmology
  • Nephrology
  • Rheumatology
  • Hormone therapies
• Plasma Fractionation Unit for plasma-derived therapeutics with WHO-GMP certification

Quality & Compliance

• Manufacturing facilities approved by major global regulatory agencies
• Adherence to highest international quality standards
• Strong in-house development and quality control systems

Core Values

• Innovation – Driving continuous improvement
• Quality – Maintaining global standards
• Added Value – Delivering beyond expectations
• Growth – Continuous progress and expansion
• Commitment – Dedication to excellence
• Customer Delight & Collaboration
• Performance Focus & Care for Society

People & Culture

• Focus on attracting and retaining top talent
• Emphasis on diversity and global workforce
• Commitment to empowering employees and fostering growth