Senior Validation Officer
Major Duties and Responsibilities
• Write, executes and reviews validation protocols in accordance with procedural requirements and current regulatory standards.
• Writes and reviews validation reports ensuring outcome of protocol objectives are documented.
• Ensures Validation Incident reports are raised, investigated with resolutions in place and closed in a timely manner.
• Ability to act as direct line manager for validation officers at D1 and D2 bands as required.
• Ensure all direct reports have objectives and development plans in place and performance is managed against objectives.
• Can act as deputy to line manager
• Mentors and supports with development of personnel in the validation team as required
• Completes statistical analysis and assessment as per the in house procedures and provides recommendations on the outcome of the analysis.
• Lead and author risk assessment, FMEA and other root cause analysis techniques to provide appropriate information on product and processes. Ability to identify suitable mitigations and actions.
• Ensures validation is in accordance with the SVMP and Regulations. Maintains a good knowledge of updates to regulations and ensures standard procedures are updated in accordance with changes to the regulations.
• Leads the execution of validation activities. Ensures all validation deliverables are met within agreed project timescales.
• Provide support and guidance to colleagues within the validation team and throughout the business on validation and qualification requirements.
• Leads key validation projects
• Monitors and reports delivery of key Quality Organisation Metrics in relation to Validation activities
• Conducts and supports with the documentation of risk assessments to identify qualification/validation requirements for new products and lifecycle products changes
• Provides guidance with process improvement projects and Tech Transfer of new products ensuring the process and cleaning validation is performed in line with procedural and regulatory requirements.
• Develop and implement systems that will improve validation activities and work efficiencies.
• Liaises and works in collaboration with other departments to ensure validation project timelines are met.
• Identifies and investigates issues and problems during validation with well defined root cause analysis and assigning appropriate corrective and preventative actions.
• Collates and supplies quality data necessary for regulatory submissions
• Ability to write standard operating procedures and WRKs. Provide guidance to the site on procedural updates to ensure all validation practices including cross contamination controls are fully compliant with regulatory requirements
• Monitors key Q metrics
• Supports internal and external audits as required
• Ability to write technical protocols and reports
• Undertakes such other reasonable duties as may be required from time to time to support the department and business activities
• Ensues safety standards are met and maintained
• Acknowledges responsibility to ensure an effective Quality Management System in order to achieve Quality Objectives
Competencies
• Leads risk assessments with a cross functional team in order to identify validation requirements for the introduction of new products or changes to existing products/processes.
• To lead and co-ordinate assigned validation projects by engaging with Area owners.
• Responds promptly to requests and concerns
• Complete business objectives
• Ensure behaviors follow company policies and departmental expectations
• Team Work
• Established Problem Solving skills
• Collaboration and Effective Communication
• Customer Service
• Business Awareness
Knowledge and Experience
• Typical Years of Experience-5+ years experience
•Minimum Expected Education-5+ years experience Level 6 – Bachelor’s
Additional Information-University degree; typically, a minimum of years experience working in a pharmaceutical GMP environment of which, at least 4 years experience is in pharmaceutical validation
Degree University degree; typically, a minimum of years experience working in a pharmaceutical GMP environment of which, at least 4 years experience is in pharmaceutical validation