QC Validation Specialist
- 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)
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