QA Associate - Validation

Description

You will support the business in meeting GDP and GMP rules so that work is done safely and efficiently, and to the quality, GDP, GMP and service levels set by the company, its clients and regulators.

Responsibilities

• Write and keep up to date the site Validation Master Plan (sVMP).
• Write validation and qualification protocols, then carry out that work as the sVMP requires.
• Qualify and validate quality-critical equipment under the relevant change controls.
• Keep complete, accurate records of all qualification, validation and other QA work.
• Help the site stay compliant with GDP, applicable GMP, ISO 9001 and client requirements.
• Stay current on the regulations that apply to the site.
• Make sure QA work follows set procedures and client instructions.
• Log quality incidents, client complaints and deviations, investigate them, and help resolve them with corrective actions completed on time.
• Make sure quality documents are approved, controlled and reviewed properly.
• Review daily and monthly temperature trends.
• Take part in client and regulatory audits, making sure documents are complete and available and giving supporting information for quality decisions when needed.
• Carry out regular Internal Compliance Inspections of operational areas, flag improvements, and agree corrective actions with the relevant process or area owners.
• Complete the relevant Key Performance Indicators (KPIs) and report weekly performance measures.
• Help with archiving and other QA documentation tasks.

Requirements

• Ideally educated to A-level or an equivalent standard.
• Ideally 3 years of experience in a validation role within a GDP or GMP environment.
• Understanding of GDP and GMP regulations.
• Understanding of ISO 9001.
• Ability to keep up with applicable regulatory and quality requirements.
• Ability to work within set procedures, quality systems and client requirements.
• Ability to complete training on all relevant procedures within 6 months.
• Good grasp of validation and qualification work in a regulated setting.
• Strong attention to detail and the ability to keep accurate, complete quality records.
• Ability to plan, organise and prioritise several tasks at once.
• Strong communication skills, able to speak clearly at every level of the organisation and with clients.
• Ability to persuade others through clear, well-structured and logical arguments.
• Strong problem-solving skills, staying calm and focused under pressure.
• Self-starter who takes ownership and sees tasks through to the end.
• Ability to build and maintain good working relationships with clients, colleagues, vendors and suppliers.
• Sound judgement, and willingness to ask for guidance when needed.
• Flexible, conscientious and committed to continuous improvement.
• Confident, professional and demonstrates integrity and respect.

Conditions

Full-time role.

Based at the site with an affiliated company.

Benefits outside the US vary by country and follow local market practice, and eligibility and start dates may differ for some benefits and for team members covered by collective bargaining agreements.

Benefits

• Benefits outside the US vary by country and follow local market practice, and eligibility and start dates may differ for some benefits and for team members covered by collective bargaining agreements.