QA Validation Specialist - GDP/GMP Compliance

Alliance Healthcare; South Normanton; On-site; GBP 42,000 - 56,000; Full time

Job summary

Cencora is seeking a QA/Validation Specialist to support GDP/GMP compliance and ensure quality standards are met across validation activities. You will develop and maintain validation plans, perform qualification activities, and support audits and client requirements.

Ideal candidates have experience in regulated environments, strong attention to detail, and the ability to work with procedures and quality systems.

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 and GMP regulations.
• Understanding of ISO 9001.
• Ability to train in all relevant procedures within the first 6 months.

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 KPIs and report weekly performance measures.
• Support appropriate archiving and other QA documentation activities.

Skills

Validation knowledge

Documentation

Planning & organisation

Communication

Problem solving

Attention to detail

Quality systems

Regulatory awareness

Education

A-level or equivalent

GDP/GMP knowledge

Job description

Cencora is seeking a QA/Validation Specialist to support GDP/GMP compliance and ensure quality standards are met across validation activities. You will develop and maintain validation plans, perform qualification activities, and support audits and client requirements.

Ideal candidates have experience in regulated environments, strong attention to detail, and the ability to work with procedures and quality systems.