Job Purpose
To support the business in compliance to GDP and GMP regulations ensuring that work is completed in a safe and efficient manner and meeting the agreed standards of quality, GDP, applicable GMP and service levels of the company, clients, and regulatory bodies.
Responsibilities
•Develop and maintain the site Validation Master Plan (sVMP)
•Develop validation and qualification protocols and perform validation and qualification activities in accordance with the sVMP
•Perform qualification and validation activities for quality-critical assets, in line with applicable change controls
•Maintain accurate and complete records of all qualification, validation and other QA activities
•Support ongoing compliance with GDP, applicable GMP, ISO 9001 and client requirements
•Maintain up-to-date knowledge and understanding of applicable regulations
•Ensure QA activities are carried out in accordance with established procedures and client instructions
•Record, investigate and support the resolution of quality incidents, customer/client complaints and deviations, ensuring appropriate corrective actions are identified and completed within agreed timescales
•Ensure quality documentation is appropriately approved, controlled and reviewed
•Review daily and monthly temperature trends
•Participate in client and regulatory audits, ensuring relevant documentation is complete and available and providing supporting information for quality decisions when required
•Perform periodic Internal Compliance Inspections of operational areas, identifying opportunities for improvement and agreeing corrective actions with relevant process/area owners
•Complete relevant Key Performance Indicators (KPIs) and report weekly performance measures
•Support appropriate archiving and other QA documentation activities
Requirements
•Ideally educated to A-level or equivalent
•Ideally 3 years' experience working in a validation role within a GDP or GMP environment
•Understanding of GDP and GMP regulations
•Understanding of ISO 9001
•Ability to maintain knowledge of applicable regulatory and quality requirements
•Ability to work effectively in accordance with established procedures, quality systems and client requirements
•Ability to complete training in all relevant procedures within the first 6 months
Minimum Skills Required
•Good understanding of validation and qualification activities within a regulated environment
•Strong attention to detail with the ability to maintain accurate and complete quality documentation
•Ability to plan, organise and prioritise multiple tasks effectively
•Strong communication skills, with the ability to communicate effectively at different levels within the organisation and with clients
•Ability to influence through clear, well-structured and rational arguments
•Strong problem-solving skills and the ability to remain calm and focused under pressure
•Ability to use initiative, take ownership and see tasks through to completion
•Ability to build and maintain effective working relationships with clients, colleagues, vendors and suppliers
•Sound judgement and willingness to seek guidance when required
•Flexible, conscientious and committed to continuous improvement
•Confident and professional approach, demonstrating integrity and respect
Full time position. Affiliated Companies: Alliance Healthcare Management Services Limited.
