Senior Director of Quality Excellence

2 days ago

Bharatpur, Rajasthan, India beBeeQualityAssurance Full time ₹ 1,20,00,000 - ₹ 1,50,00,000

Quality Assurance Expert

We are seeking a seasoned Quality Assurance professional to lead our team in ensuring the highest standards of product quality. As a Group Leader for Developmental Quality Assurance, you will oversee quality systems across R&D and pilot stages.

  • Key Responsibilities:
  • Develop and implement comprehensive quality assurance plans that meet regulatory requirements.
  • Collaborate with cross-functional teams to design and execute experiments, DOE, hypothesis studies, and protocols for process development.
  • Ensure seamless technology transfer from R&D to Pilot plant and Site level, sharing relevant documents and overseeing QA-technical transfer to sites.
  • Manage overall DQA & Kilo Lab operations, including budgeting, talent acquisition and retention, and compliance with SOPs, policies, standards, guidelines, and customer requirements.
  • Drive innovation by studying and improving material flowability and free-flow characteristics of APIs/ingredients, powders, supplements, bulk density, compressibility, and particle shape, size, and angle of repose.
  • Implement advanced physical characterization techniques, including SEM, TEM, XRD, DLS, and laser diffraction, to analyze API, ingredient properties.
  • Define and set process conditions for hygroscopic materials handling, packing configuration, storage conditions, and RH to prevent lumping and agglomeration issues.
  • Apply analytical and problem-solving skills to analyze complex data, identify process optimization opportunities, and ensure smooth technology transfer of crystallization and powder processing technologies.
  • Coordinate with internal stakeholders to review and sign-off tech packs, release timely to site, and generate regular DQA reports for management review.
  • Utilize strong project management skills to prioritize tasks, manage timelines, and deliver results under tight deadlines.

Requirements:

  • Expertise in Quality Assurance, regulatory compliance, and pharmaceutical industry best practices.
  • Strong understanding of crystallization principles, techniques, and equipment, including batch and continuous crystallization methods.
  • Knowledge of material science, chemistry, and physics principles applicable to API/ingredient characterization.
  • Experience with experimental design, DOE, hypothesis studies, and protocol development for process improvement.
  • Excellent communication, collaboration, and leadership skills to drive quality excellence.
  • Ability to work in a fast-paced environment, prioritize multiple tasks, and meet deadlines.

What We Offer:

  • A dynamic and supportive work environment that fosters growth and development.
  • The opportunity to work on high-profile projects and contribute to business success.
  • A competitive compensation package and benefits.
  • Ongoing training and professional development opportunities.

Join Our Team:

  • As a Quality Assurance expert, you will be part of a talented team dedicated to delivering exceptional products and services.
  • Together, we will push the boundaries of innovation and excellence in quality assurance.

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