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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