Quality Assurance Specialist

Job Description

We are currently hiring a Quality Assurance Specialist to join our team in Grossbeeren, Germany.

Main responsibilities:

• Qualification and validation of equipment, facilities, utilities, processes.
• Conducting risk analyses of new production processes.
• Creating qualification plans.
• Creating and reviewing qualification and validation documents (URS, DQ, IQ, OQ, PQ).
• Creating process documentation and evaluating the results.
• Coordination and cooperation with other departments to drive projects forward in a target-oriented manner.
• Availability for audits on the topics of qualification and validation.
• Change control and deviation management.
• Run temperature mappings.
• Implementation of the defined quality objectives.
• Structuring and monitoring of quality tasks you initiated.
• Assist in the execution of tasks related to the daily aspects of Quality Assurance.
• Develop and review SOPs, work instructions and forms.
• Preparation of qualification and/or validation documents related to instruments, equipment, facilities (including cold storage), utilities, manufacturing and cleaning processes, including URS, risk analysis, IQ, OQ, MQP, PQ.
• Review and adhere to the site qualification master plan.
• Establish and monitor a register of equipment to be qualified and validated.
• Discuss validation requirements for new orders with customers.
• Assigning appropriate corrective actions and implementing them in a timely manner.
• Conduct periodic reviews and re-qualifications with ongoing process reviews.
• Assist with all regulatory inspections, customer visits and customer audits related to qualification and validation related issues as required.
• Training and supporting employees in terms of qualification / validation topics.

Experience and Qualifications:

• 2-3 Years’ Experience within a quality systems related role (ideally pharma related).
• Proven expertise in qualification and validation of rooms, equipment, processes and utilities.
• Ability to run temperature mappings.
• Demonstrable experience within Quality department, ideally in a packaging or pharmaceutical company.
• Good knowledge of Quality Assurance inspection requirements.
• Risk Analysis and associated methodology.
• Trained in GMP requirements.
• Fluent in business English and German (in speech and writing).
• Good interpersonal and Teamwork skills.
• Strong commitment to Quality Assurance principles.
• Analytical approach / attention to detail.
• Self-motivated and organised.