Quality Assurance Specialist
vor 4 Monaten
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.
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.#LI-VR1
Join us and be part of building the bridge between life changing therapies and patients.
-
Senior Quality Assurance Specialist
vor 4 Monaten
Grossbeeren, Deutschland PCI Pharma Services VollzeitLife 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: The role...
-
Senior Quality Assurance Specialist
vor 3 Wochen
Grossbeeren, Deutschland PCI Pharma Services VollzeitWir suchen einen Senior QA Specialist zur Verstärkung unseres Team in Großbeeren.Hauptaufgaben: Aufsicht über die zugewiesenen Bereiche des Qualitätsmanagementsystems, zu denen unter anderem auch Folgendes gehören würde:Führen, unterstützen, entwickeln und betreuen Sie die Mitglieder des QA-Teams unter ihrer direkten Aufsicht.Umsetzung der...
-
Senior Quality Assurance Specialist
vor 3 Wochen
Grossbeeren, Deutschland PCI Pharma Services VollzeitWir suchen einen Senior QA Specialist zur Verstärkung unseres Team in Großbeeren.Hauptaufgaben: Aufsicht über die zugewiesenen Bereiche des Qualitätsmanagementsystems, zu denen unter anderem auch Folgendes gehören würde:Führen, unterstützen, entwickeln und betreuen Sie die Mitglieder des QA-Teams unter ihrer direkten Aufsicht.Umsetzung der...
-
Warehouse Operator I
vor 4 Monaten
Grossbeeren, Deutschland PCI Pharma Services VollzeitLife 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. JOB POSTING: Job: Warehouse...
-
Production Operator
vor 2 Monaten
Grossbeeren, Deutschland PCI Pharma Services VollzeitLife 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 TASKS AND RESPONSIBILITIES: ...
-
Controller (m/w/d) Contract Logistics
vor 4 Monaten
Grossbeeren, Deutschland CEVA Logistics VollzeitCEVA Logistics provides global supply chain solutions to connect people, products and providers all around the world. Present in 170 countries and with more than 110,000 employees spread over 1,300 sites, we are well on our way to achieving our vision: to be a Top 5 global 3PL. We believe that our employees are the key to our success. We want to engage and...