QC Validation Specialist

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)