Overview

DUTIES AND RESPONSIBILITIES:

  • The execution and completion of process, systems and equipment validations and revalidations in accordance with Validation Master Plans, schedules and Company policy.
  • Prepare, execute and complete Validation Protocols and Reports, ensuring compliance to all relevant Quality Standards and Regulatory requirements.
  • As assigned, participate in cross functional teams to establish validation strategies and objectives to support process and equipment changes.
  • Ensure all departments understand and comply with the requirements of cGMP as applied to the validation program for the Membrane plant. As needed, assist in providing related training and support.                                                             
  • Provide guidance and support to all departments/staff as needed regarding related issues, ensuring compliance, as applicable, with 21 CFR , ISO13485 and all other Quality Standards, Validation Regulations and Guidance Documents.
  • Maintain on-going understanding and knowledge of the latest regulatory requirements for validation in compliance with EU/U.S. regulations and guidance documents. Provide related updates to department management according to the latest EU/U.S and ICH requirements.             
  • Ensure compliance with Software and Hardware Validation regulatory requirements, 21 CFR part 11, GAMP and other guidance documents, as appropriate to the business needs.
  • Monitor the progress of validation projects on a daily/weekly basis ensuring that there is continuous drive/focus on meeting schedules.
  • Participate in the review of validation practices for the membrane plant; monitor trends, and initiate improvement opportunities.  Escalate any out-of-norm matters to department management as applicable.
  •  Any other responsibility as set out by Supervisor/ Manager

KNOWLEDGE/SKILLS/EXPERIENCE

  • A qualification in appropriate Quality Assurance/Science discipline and at least 5 years relevant experience in a regulated environment
  • Good regulatory knowledge
  • Good verbal and written communication skills, including the ability to conduct verbal presentations.
  • Demonstrated success working in a team environment.
  • Ability to work under pressure to meet scheduled deadlines
  • Proven technical protocol and report writing skills
  • Ability to design and implement validation programs
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