QA Validation Specialist — GDP & GMP Compliance

Cencora, Inc.; United Kingdom; Sur place; GBP 32 000 - 48 000; Plein temps

Résumé du poste

Cencora, Inc. in the United Kingdom is seeking a QA/Validation specialist to ensure GDP and GMP compliance and safe, efficient work. You will help ensure that quality standards are met for clients and regulatory bodies.

The role involves developing sVMP, validating processes, maintaining records, and supporting audits. The successful candidate will have experience in GDP/GMP environments and strong attention to detail.

Qualifications

• Ideally educated to A-level or equivalent.
• Ideally 3 years' experience in a validation role within a GDP or GMP environment.
• Understanding of GDP, GMP regulations and ISO 9001.
• Ability to work with quality systems and client requirements.
• Ability to complete training in all relevant procedures within the first 6 months.

Responsabilités

• 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

Connaissances

Validation activities

Quality documentation

Regulatory compliance

GDP/GMP knowledge

Attention to detail

Cross-functional collaboration

Formation

A-level or equivalent

Description du poste

Cencora, Inc. in the United Kingdom is seeking a QA/Validation specialist to ensure GDP and GMP compliance and safe, efficient work. You will help ensure that quality standards are met for clients and regulatory bodies.

The role involves developing sVMP, validating processes, maintaining records, and supporting audits. The successful candidate will have experience in GDP/GMP environments and strong attention to detail.