Quality compliance team leader

Role Description

My client is a multi-national pharmaceutical manufacturing company. We are recruiting a Quality compliance team leader to join their sciences team.

The Role

GENERAL

  • Day to day management of a team of Quality Compliance Officers and Technicians supporting project and quality compliance work.
  • Assist in the development and maintenance of the Quality System
  • Actively participate in and promote GMP improvement initiatives throughout.
  • Support GMP training program.
  • Communicate fully and effectively project and compliance progress and issues to Quality Compliance Manager

LINE MANAGEMENT

  • Support Quality Compliance Officers and Technician with project work to ensure that projects assigned to the team are completed within agreed timelines.
  • Coordinate the job specific training requirements of Quality Compliance Officers and Technicians ensuring team members have the appropriate training to perform the tasks assigned.
  • Monitor individuals performance and provide feedback, mentoring and leadership ensuring that they are highly motivated and work effectively and efficiently on their tasks.
  • Ensure that Quality Events raised within the Compliance team are investigated and CAPA actions are progressed in a timely manner.

QUALITY

  • Provide QA support to manufacturing and analytical projects as required both for clinical and commercial projects ensuring GMP compliance and Customer requirements are met.
  • Release GMP intermediates and APIs for IMP and Commercial drug product use ensuring compliance to GMP, procedures and customer quality requirements.
  • Participate in quality investigations and quality risk assessments ensuring that effective CAPA actions are implemented.
  • Perform supplier audits, acting as the lead auditor, as required.
  • Participate in and host Customer audits and visits
  • Participate in Regulatory Authorities when required.
  • Prepare and approve Quality Technical Agreements as required.
  • Conduct internal audits and QA walkthroughs in order to verify compliance with the principles of GMP.
  • Assist in the maintenance of Quality systems as required.
  • Write, approve or authorise SOPs as required. Review QA SOPs as required to ensure their continual effectiveness and compliance with the principles of cGMP.
  • Develop and deliver training on Quality topics i.e. SOPs and Quality Systems

The Person

  • Third level qualification in a scientific discipline.
  • Significant experience in a QA role within the pharmaceutical industry supporting GMP manufacturing activities.
  • Supervisory experience and/or previous experience acting as QA advisor to operational departments.
  • Experience reviewing Analytical Validation documentation
  • Proven GMP knowledge.
  • Excellent verbal and written communication skills

 

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