Quality Assurance Specialist
vor 2 Wochen
Life-changing therapies are at the heart of our mission at PCI Pharma Services. We're a global leader in the biopharma industry, connecting thousands of companies and their patients through our innovative solutions.
Our Investment in People
We believe that our people are our greatest asset. That's why we're committed to building a team of talented individuals who share our passion for quality and innovation. As a Quality Assurance Specialist, you'll play a critical role in shaping the future of our company.
Main Responsibilities:
- Qualify and validate equipment, facilities, utilities, and processes to ensure compliance with regulatory requirements.
- Conduct risk analyses of new production processes to identify potential hazards and implement mitigation strategies.
- Create qualification plans and documents, including URS, DQ, IQ, OQ, and PQ.
- Develop and review SOPs, work instructions, and forms to ensure compliance with GMP requirements.
- Coordinate with other departments to drive projects forward and ensure timely completion.
- Assist in the execution of tasks related to daily aspects of Quality Assurance.
- Develop and review qualification and validation documents related to instruments, equipment, facilities, and manufacturing processes.
- Review and adhere to the site qualification master plan.
- Establish and monitor a register of equipment to be qualified and validated.
- Discuss validation requirements with customers and assign corrective actions as needed.
- Conduct periodic reviews and re-qualifications with ongoing process reviews.
- Assist with regulatory inspections, customer visits, and audits related to qualification and validation issues.
- Train and support employees on qualification and validation topics.
Experience and Qualifications:
- 2-3 years' experience in a quality systems-related role, preferably in the pharmaceutical industry.
- Proven expertise in qualification and validation of rooms, equipment, processes, and utilities.
- Ability to run temperature mappings and conduct risk analyses.
- Demonstrable experience within Quality department, ideally in a packaging or pharmaceutical company.
- Good knowledge of Quality Assurance inspection requirements and GMP regulations.
- Risk Analysis and associated methodology.
- Fluent in business English and German (in speech and writing).
- Good interpersonal and teamwork skills.
- Strong commitment to Quality Assurance principles.
- Analytical approach and attention to detail.
- Self-motivated and organized.
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