GER_Quality Assurance Specialist

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI. 

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Main purpose of job:

As a quality assurance specialist, your responsibilities in the Quality department will focus on validation and qualification of equipment, systems, utilities, etc. in accordance with GMP guidelines. You will create qualification plans and reports and be responsible for the implementation of qualification and validation activities.

With that you will also be involved in internal coordination and communication with various stakeholders and be responsible for conducting trainings on the qualification and validation.

On top you will also support the implementation and execution of tasks related to the day-to-day aspects of quality assurance (such as but not limited to: CAPA, Deviations, SOP, Complaints, etc).

Main responsibilities:

Qualification and validation of equipment, facilities, utilities, processes, etc Carrying out risk analyses of new production processes Creating qualification plans Creating and reviewing qualification and validation documents (URS, DQ, IQ, OQ, PQ etc.) 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, etc 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 of employees in terms of qualification / validation topics

Specification:

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 skills Appreciates teamwork Strong commitment to Quality Assurance principles Analytical approach / attention to detail Self-motivated and organised Ability to convince stakeholders

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Join us and be part of building the bridge between life changing therapies and patients.

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