Director of Quality Management

4 days ago

Amrāvati, Maharashtra, India beBeeQualityControl Full time ₹ 1,80,00,000 - ₹ 2,00,00,000

Job Title: Director of Quality Control

We are seeking an experienced professional to lead our quality control function across R&D and pilot stages.

Responsibilities:

  • To oversee the developmental Quality Assurance function across JVL-R&D & Development Quality of new products, including DQA & Lab – Analytical assurance.
  • To set up a robust stage gate system for new products at R&D and Pilot stage, ensuring right first-time quality of products designed for commercial viability and scalability.
  • To design experiments, DOE, hypothesis study, and conduct experiments with R&D and Technology teams.
  • To develop protocols for experiments, process development, study robustness, evaluate process performance between R&D to Pilot plant and site level.
  • To play a key role in technology transfer from R&D to Pilot plant and Site level, share relevant documents, and ensure QA–tech transfer to sites.
  • To manage overall DQA & Kilo Lab budget – Capex, opex, hiring, and retention of talent.
  • To ensure compliance of SOPs, Policies, standard, guideline, regulatory, and customer requirements.
  • To possess in-depth knowledge of crystallization principles, techniques, and equipment, including batch and continuous crystallization methods.
  • To study and improve material flowability and free-flow characteristics of API/ingredients, powders, Supplement.
  • To set up a system to analyze and enhance bulk density, compressibility, and particle shape, particle size of materials, angle of repose.
  • To implement strategies for particle size engineering, including micronization, granulation, and agglomeration.
  • To design and conduct advanced physical characterization of APIs, ingredients, including particle size distribution, morphology, porosity, and surface area analysis.
  • To set up a process to utilize techniques like SEM, TEM, XRD, DLS, and laser diffraction for material evaluation.
  • To be an expert in defining and setting process conditions, including RH for Hygroscopic materials handling, their packing configuration, and storage conditions to avoid lumping and agglomeration issues.
  • To possess strong analytical and problem-solving skills, including ARD, (Analytical/QC/instruments knowledge) with the ability to analyze complex data and identify process optimization opportunities.
  • To ensure smooth technology transfer of crystallization and powder processing technologies.
  • To coordinate with Business, Technology absorption cell, site QA, and internal CFTs to ensure smooth functioning, closing of stage gate process in the system timely, review, and sign-off of tech-pack and release timely to site.
  • To possess strong project management skills, with the ability to prioritize tasks, manage timelines, and deliver results under tight deadlines.
  • To generate monthly, weekly, and periodic DQA reports with management and apprise quality-related issues in new projects with areas of improvement.

The Ideal Candidate:

We seek an individual with M. Sc/M.Pharma– Chemistry, 16-24 years of experience in API/Intermediate/Fine chemical Industry, sound knowledge of Fine chemical, DQA is must with good knowledge of product development at R&D stage.

Personal Characteristics include Openness and Transparency, Willingness to learn & grow, dynamic, self-driver work towards excellence in regulatory filing, & compliance across the regions. Self-Motivated and work towards achievement of organizational goals.

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