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CMC Manager

4 months ago

india Vita Green Health Product Company Limited Full time

Job Purpose:

The position will be overseeing Chemistry, Manufacturing, and Controls (CMC) activities, ensuring the highest quality and compliance standards. Responsibilities will encompass a range of tasks, including technical writing, collaboration with manufacturing sites, and close coordination with Quality Assurance (QA) and Quality Control (QC) functions.

Main Tasks:

CMC Oversight:

  • Manage all aspects of CMC activities for pharmaceutical and consumer health products, encompassing formulation development, process optimization, and analytical methods.

 

Technical Writing:

  • Develop and maintain precise technical documentation, including CMC regulatory submissions (INDs, NDAs, MAA, Food supplement dossier, Cosmetics etc.).
  • Create and update product specifications, master batch records, and standard operating procedures.

 

Manufacturing Site Liaison:

  • Serve as the primary point of contact between the organization and manufacturing sites.
  • Collaborate closely with manufacturing teams to ensure alignment with CMC strategies and objectives.

 

Quality Assurance/Quality Control Collaboration:

  • Work collaboratively with QA and QC teams to implement and maintain quality standards throughout the manufacturing process.
  • Participate in the development and execution of quality initiatives.

 

Regulatory Compliance:

  • Stay abreast of regulatory changes and industry trends impacting CMC requirements.
  • Ensure ongoing compliance with relevant regulations and guidelines.
  • Prepare and review CMC sections of regulatory submissions to health authorities.

 

Process Optimization:

  • Identify opportunities for process improvements and efficiency enhancements in collaboration with manufacturing teams.
  • Implement changes to enhance the robustness and reliability of manufacturing processes.

 

Supply Chain Coordination:

  • Collaborate with supply chain teams to manage inventory levels and ensure timely production and distribution.
  • Implement strategies to enhance the reliability of the supply chain for pharmaceutical and consumer health products.

Requirements

  • Bachelor's or advanced degree in a relevant scientific or engineering discipline.
  • Proven experience in CMC management within the consumer health or related industries.
  • Technical writing expertise with the ability to articulate complex CMC concepts in regulatory submissions.
  • In-depth knowledge of formulation development, process optimization, and analytical methods in a consumer health context.
  • Familiarity with regulatory requirements and guidelines related to consumer health products.
  • Project management skills to oversee CMC processes and timelines.
  • Effective communication skills to liaise with manufacturing, QA, QC, and regulatory teams.
  • Collaborative mindset with the ability to work across functional areas.
  • Knowledge of quality systems and practices in the pharmaceutical or consumer health sector.
  • Adaptability to evolving industry standards and regulatory landscapes.

Benefits

We offer you...

  • Growth Opportunities for strong performers
  • Flexible working schedule
  • Chance to work on cutting edge technology
  • Fun working culture

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