QA Associate - Validation

Job Purpose: We are seeking a dedicated QA Associate - Validation to join our team at Alloga, a Cencora Company UK. In this role, you will play a crucial part in supporting the business in compliance with Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP) regulations. Your focus will be on ensuring that all work is completed safely, efficiently, and to the highest quality standards as set by our company, clients, and regulatory bodies.,

• Ensure all accidents and near misses are reported immediately to the Health & Safety Manager.
• Perform all QA department activities in accordance with company procedures and client instructions.
• Document all QA activities appropriately.
Validation Responsibilities:
• Develop and maintain the site Validation Master Plan (sVMP).
• Develop validation and qualification protocols.
• Perform qualification and validation activities in line with the sVMP.
• Conduct qualification and validation of quality-critical assets following applicable change controls.
• Record all qualification and validation activities accurately.
• Report weekly performance measures.
Compliance Responsibilities:
• Maintain a current understanding of relevant regulations.
• Ensure QA activities comply with defined procedures and client instructions, maintaining appropriate records.
• Record, investigate, and communicate quality incidents, client/customer complaints, and deviations.
• Ensure corrective actions are carried out within agreed timescales.
• Manage quality documents to ensure they are approved, controlled, and reviewed correctly.
• Prepare for and participate in audits, providing supporting data for quality decisions.
Additional Responsibilities:
• Review daily and monthly temperature trending.
• Participate in client and regulatory audits.
• Maintain records of QA activity and complete key performance indicators (KPIs) relevant to the role.
• Archive paperwork and manage the removal of TMDs for destruction.
• Perform periodic internal compliance inspections to identify improvement opportunities., Supervisors
• Managers
• Clients
• Vendors/Suppliers
  
  Effective communication at all levels within Alloga UK and with clients.
• Ability to influence through rational arguments and compromise when necessary.
• Maintain composure under pressure and focus on problem resolution.
• Build and maintain harmonious working relationships with clients and colleagues.
• Demonstrate initiative, ownership, and task completion., Flexible approach to work with strong planning and prioritisation skills.
• Confident, enthusiastic, respectful, and exhibits integrity.
• Willingness to learn from mistakes and make sound decisions.
• Drive for success and self-development, with a conscientious attitude toward performance improvement.
• Excellent attention to detail.
Knowledge, Skills, and Experience Required
• Ideally educated to A-level or equivalent.
• A minimum of 3 years' experience in a validation role within a GDP or GMP environment.
• Understanding of GDP and GMP regulations, as well as ISO 9001.
• Must complete training in all relevant procedures within 6 months.
  
  Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!