CMC Manager

2 weeks ago


Delhi, Delhi, 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.

RequirementsBachelor'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.
BenefitsWe offer you...Growth Opportunities for strong performersFlexible working scheduleChance to work on cutting edge technologyFun working culture

#LI-CJ
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