Home Head/VP/CEO/President/GM Dy General Manager | Alkem Laboratories | Mumbai

Dy General Manager | Alkem Laboratories | Mumbai

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Founded 4 Decades ago Alkem Laboratories is now amongst India’s largest Generic and Specialty Manufacturing Company

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Alkem has registered Many Brands amongst the Top 50 Brands in India Like, Clavam, Taxim, Pan, Pan D. The dominance of Alkem in the Anti Infective segment remains unchallenged.

Alkem has 21 Manufacturing Units in India and Across The world, and are Inspected by Worlds main Regulatory Bodies and Approved like USFDA/MHRA/TGA, etc

Position: Dy General Manager – Quality By Design

Location: Mumbai, Maharashtra, India

Job Description:

  • To provide inputs for designing QbD based experimentation strategy for formula and process optimization,
  • data modeling and data analysis with Design Expert by Stat-Ease and JMP, interpretation of results, and provide the way forward.
  • Establishment of scale correlation principles from laboratory scale to pilot scale and their implementation during drug product development
  • Evaluation of process analytical technology tools in product development
  • To guide review of various QbD elements and to provide inputs/recommendations for risk mitigation plans
  • Review of product development report from QbD perspective
  • Provide scientific insight on the regulatory queries and to provide support to regulatory affairs department
  • for timely response and approval.
  • Provide training to supervise Associate Scientists/Research Associates/Trainees with respect to QbD principles and their implementation in product developments.
  • Establishment of systems and SOPs for creating harmonized practices

Qualification: B.Pharma/M.Pharma/Ph.D.

Experience: 10-17 Years

Salary: Negotiable

Contact Details:

hrd@alkem.com, swati.upadhyay@alkem.com

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