QA Engineer validating document automation applications for PwC document automation team in Prague. Key role in quality assurance and coordination with cross - functional teams to enhance output.
About the role
- Managing quality assurance for external suppliers in the pharmaceutical industry. Ensuring compliance with cGMP and regulatory requirements for biologics production.
Responsibilities
- Responsible for managing quality aspects at external suppliers to ensure compliance with cGMP and regulatory requirements
- Provides direction and formulates strategies to maintain and improve external supplier quality oversight
- Establishes and maintains quality relationship with suppliers
- Acts as Single Point of Contact / SPOC for all quality related activities
- Provides quality presence and input to technical meetings with external suppliers
- Conducts necessary trainings for assigned duties
- Ensures valid Quality Agreement and external supplier quality risk assessments are in place
- Ensures site readiness for regulatory inspections and quality audits
- Assesses quality trends and drives continuous improvement
- Manages all quality issues (complaints, deviations)
- Ensures investigations and required actions are taken timely
- Ensures activities related to change requests are managed appropriately
- Ensures QA Oversight during product transfers
- Implements and monitors Key Performance Indicators (KPI)
Requirements
- Bachelor or higher in Biochemistry, Chemistry, Microbiology or a related science
- Fluent English mandatory
- Min 8 years of experience in the pharmaceutical industry.
- Min 5 years of experience in manufacturing of sterile pharmaceuticals.
- Expert knowledge in biosimilar pharmaceutical processes and manufacturing of biologics.
- Min 5 years of experience in operational quality assurance.
- Expert knowledge of cGMP requirements for major regulated markets (EU, US).
- Advanced experience with FDA, EMEA and other Health Authorities.
- Expert in risk management.
- Advanced understanding of project management.
- Expert in communication and advanced negotiation skills.
- Advanced decision-making skills.
- Basic leadership skills.
Benefits
- Commitment to Diversity & Inclusion
- Professional development opportunities
- Inclusive work environment
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
Group Quality Assurance Manager ensuring quality assurance processes in construction projects across multiple locations. Train and support teams to achieve high standards in quality and compliance.
Senior Quality Engineer ensuring quality throughout Matillion's development process for data integration. Driving focus on quality and mentoring team members in a collaborative environment.
Lead QA Automation initiatives and design automated frameworks for Public Group’s digital retail solutions. Collaborate with diverse teams to enhance testing processes and product quality.
QA Engineer implementing automated tests for Voyage Privé's innovative travel tech platform. Collaborating with cross - functional teams in a modern tech environment with Cucumber and Playwright.
Associate Director of Quality Assurance Compliance managing inspection operations and regulatory compliance at Gilead. Collaborating with global teams to enhance inspection strategies and processes.
QA Tester developing software quality assurance expertise at CBTW consultancy. Collaborating on testing strategies and conducting software tests to improve quality standards.
NDT Engineer at Zurich Engineering conducting inspections on pressure equipment and supporting colleague development. Requires PCN Level 2 qualifications and offers flexible working arrangements.
Director of Quality Assurance managing compliance in clinical trial operations for gene therapies. Involved in ensuring GLP, GCLP, and GCP regulatory compliance across various teams.
SQA Senior Analyst ensuring software quality assurance and managing usability tests in projects. Focused on delivering stable and reliable solutions for the business.