Job Information
PCI Pharma Services Quality Assurance Specialist in Grossbeeren, Germany
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. Let’s talk future (https://pci.com/)
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
PCI Pharma Services
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