Quality Assurance Officer - Derby, United Kingdom - Tentamus UK

Description

Tentamus UK are currently seeking a Quality Assurance Officer to work in our QA department at our GMP pharmaceutical site in Derby.

Reporting to the QA Manager this position is responsible for undertaking general QA activities in support of the Operations department.

As a service provider you will be a key position ensuring we deliver excellence in quality and turnaround to our customers.

Our laboratory operates according to EU cGMP, experience of working in a GMP environment is an advantage but is not essential.

• Comply with company SOPs
• Provide input and assessment to equipment qualification
• Support batch release activities
• Prepare customer test/technical protocols and reports
• Record all activities on relevant databases
• Effectively manage quality assurance activities including change controls, nonconformances, corrective and preventive actions, OOS, training, risk assessment, document distribution and trending when required
• Periodic review of test methods and specifications
• Revise the specification documents
• Manage the customer complaints
• Produce weekly / monthly activity and performance reports for Management
• Maintenance of Pharmaceutical Quality System documentation
• Ensure that the core current Good Manufacturing Practice (cGMP), Good Control Laboratory Practice (GCLP), and Data Integrity are maintained
• Initiate, write and review SOPs as required
• Coordinate internal audits
• Coordinate SOP / documentation management system (Gdocs) and provide technical support and training to Tentamus Pharma UK staff.

• First degree in scientific discipline
• 1 3 years' experience in responsible and equivalent position within GMP environment.
• Fully competent in oral and written communications with strong interpersonal and management skills.
• Ability to work well and collaborate within a team environment
• Excellent communication skills in providing feedback and pinpointing improvements where needed
• Have keen attention to detail to ensure all products and services meet standard requirements

• Highly computer literate, e.g. Microsoft Office

• Casual dress
• Onsite parking

• Holidays
• Monday to Friday