Marketplace Technical

QC Validation Specialist

England, Borehamwood, Hertfordshire
19 Jun 2021
25 Jun 2021
Andrew Williams
Full Time
Contract Type
Experience Level
Experienced (non-manager)

International Pharmaceutical Manufacturer requires an experienced QC Validation Specialist, to support the laboratory by providing specialist knowledge and problem-solving ability for all analytical techniques, problematic results, and validation requirements across the section and working as the subject matter lead.

Duties may include:

  • Plan own validation activities and activities for the Quality Laboratories, ensuring delivery on timelines.
  • To assist with the delivery of departmental objectives.
  • Ensure that KPIs are met.
  • Support the progression of Minor and Major deviations
  • Provide technical support for critical deviations.
  • Support site driven investigations and improvements
  • An SME for QC validation, providing the training and support for inexperienced member of staff to increase their knowledge/ability in validation activities.
  • SME supporting department in quality records for technical issues/guidance
  • To assist with the implementation of change controls and to implement agreed actions.
  • Support improvements to the training programme and assessment criteria.
  • Review and approval technical documents
  • Training and development of staff preparing such documentation
  • Attend cross functional meetings providing expertise and knowledge
  • Support and help deliver validation activities identified by the business and Quality manager, working within the Technical Development department.
  • Liaising with Team Leader to ensure available resource to enable delivery of work for the business is achieved
  • Support preparation of departmental CAPEX requirements
  • Providing mentoring to technical staff.
  • Assisting with the development of training programmes.
  • Working with QC validation Team Leader to implement and support projects within the QC Department.
  • Ensure that agreed section and project timelines are implemented and achieved.
  • Train staff in validation activities, to enable the right level of support required to achieve workload.
  • Identify, and validate new equipment within QC.
  • Prepare and review validation life-cycle documentation.
  • To adhere to ICH and regulatory guidelines for analytical method validation.
  • Have a strong knowledge of validation requirements within a GMP environment to enable correct level of validation for specific regions and resolution of issues.
  • Work cross-functionally with other departments or teams.
  • To attend meetings as required.
  • To lead technology transfer and validation projects.
  • To take responsibility for and deliver training and coaching to all members of the department.
  • Ensure work is in line with regulatory requirements and guidelines.
  • To ensure data trend reviews and analysis is performed.
  • To take part and to lead continuous improvement initiatives.
  • To participate with the receipt of audits from internal and external sources.
  • Provide specialist advice to the Team Leader and Quality Manager for problem solving and fault diagnosis.
  • To assist staff with the implementation of policies, following cGMP guidelines.
  • Preparation of technical documentation such as procedures, protocols and reports.
  • Preparing documents and responses for regulatory submission.

Skills and experience:

  • Significant experience in a laboratory environment, with a focus on Technical knowledge of Methods
  • Significant equipment validation experience in a QC environment.
  • Good knowledge/understanding of GMP/GLP.
  • Experience of raising, completing, and investigating quality records.
  • Project management experience.
  • Knowledge of industry guidelines.
  • Experience of writing protocols and reports.
  • BSc in relevant subject (or equivalent experience)