QA Validation Team Lead

  • Cork
  • Permanent
  • JO-1706-62596_1497515315

Summary

Reporting to the QA Director, The QA Validation Team Lead will:

  • Assure cGMP compliance before, during and after validation/qualification activities by assuring that all necessary procedures are implemented and are being followed on the site.
  • Approve and/or carry out the Design, Installation, Operational Qualification and Performance Qualification of new or changed process systems, equipment, utilities and facilities. Conduct 21 CFR part 11 assessments.
  • To co-ordinate and coach QA, Engineering, Maintenance and Manufacturing areas, promoting a continuous improvement culture compliant with the applicable regulations and approved procedures


Responsibilities
Provide cGMP and Technical Guidance on Validation activities on site.

  • To plan and establish Qualification/Validation requirements for each project.
  • To assure that systems, including automated process control systems, equipment, utilities and facilities are qualified/validated according to their intended use and product requirements in accordance with Procedures and Regulatory Guidelines.
  • To promote the importance of high quality standards and the importance of a continuous improvement culture in core company activities.
  • To participate in the alignment and harmonization of the Qualification and Validation procedures within all sites.
  • To align Qualification and Validation methodologies in Automation, Engineering, Maintenance, and Production Areas to benefit systems compliance.
  • To establish the required qualification activities of new or changed systems and/or facilities within the change control process.
  • To conduct periodic review of systems.
  • Provide guidance on validation activities for APIs and DPIs on site.
  • Generate or approve protocols, reports and periodic reviews of systems.
  • Approve equipment, maintenance and automation Change Control Requests
  • Coordinate and/or carry out the URS/DQ/IQ/OQ tasks, for all new or changed process/utilities systems in close liaison with the Engineering area.
  • To participate in the management of Quality Systems key activities related to the job mission, procedures, policies and cGMPs training.
  • To prepare/review/approve Quality Systems methodologies related to the area objectives and assuring adequate training on site is provided to all departments in relation to validation/qualification activities.
  • To assure and promote compliance on Health, Safety and Environment.
  • To establish qualification/validation related procedures and documents.
  • To actively participate in customer audits.
  • To support all regulatory inspections.
  • To pro-actively manage all Deviations, CAPAs, Improvement Plans and Change Control activities related to Qualification and Validation of all Projects, Equipment, Facilities and Utilities.


Requirements

  • BSc Chemistry or equivalent
  • Minimum of 4 years' experience in Qualification & Validation work with at least 2 years' experience gained in a commercial API environment;
  • Good general knowledge on Quality, cGMPs, ICH and ISO guidelines as well as experience on their application;
  • Strong Technical Knowledge of Project Engineering applied to Process equipment, facilities, utilities and HVAC systems
  • Formalised Training in Risk Assessment/Analysis techniques
  • Excellent communication skills;
  • Ability to discuss technical aspects of Qualification and Validation with clients, suppliers and health authorities;
  • Proactive approach to all activities - "Can do - Will Do" attitude
  • Excellent attention to detail with an analytical and objective approach to review
  • Must be able to work on own Initiative with minimal supervision.

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