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Title

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CMC Officer

Description

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We are looking for a dedicated and experienced CMC Officer to join our team. The CMC Officer will be responsible for overseeing all aspects of Chemistry, Manufacturing, and Controls (CMC) including the development, implementation, and maintenance of CMC strategies. The successful candidate will have a strong understanding of pharmaceutical manufacturing processes, regulatory requirements, and quality control procedures. They will also have excellent leadership skills, with the ability to manage a team and ensure all CMC activities are carried out in accordance with company policies and regulatory guidelines. The CMC Officer will also be responsible for liaising with other departments, coordinating CMC activities, and ensuring all documentation is accurate and up-to-date.

Responsibilities

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  • Develop and implement CMC strategies.
  • Oversee all CMC activities.
  • Ensure compliance with regulatory guidelines.
  • Manage a team of CMC professionals.
  • Coordinate with other departments.
  • Maintain accurate and up-to-date documentation.
  • Monitor and improve manufacturing processes.
  • Ensure quality control procedures are followed.
  • Liaise with regulatory bodies.
  • Keep up-to-date with industry developments.

Requirements

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  • Degree in Chemistry, Pharmacy, or related field.
  • Experience in a CMC role.
  • Strong understanding of pharmaceutical manufacturing processes.
  • Knowledge of regulatory requirements.
  • Excellent leadership skills.
  • Strong communication skills.
  • Attention to detail.
  • Ability to manage a team.
  • Good problem-solving skills.
  • Ability to work under pressure.

Potential interview questions

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  • What experience do you have in a CMC role?
  • How do you ensure compliance with regulatory guidelines?
  • How do you manage a team of CMC professionals?
  • How do you coordinate with other departments?
  • How do you ensure quality control procedures are followed?