Quality Assurance Engineer
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Job Location:
Monthly Salary:
Posted on:
9 hours ago
Vacancies:
1 Vacancy
Job Summary
We are seeking a Quality Assurance Engineer with experience in lyophilization systems to ensure compliance validation and quality excellence across equipment and processes. The role will involve working across the equipment lifecycle including exposure to Design Qualification (DQ) and Factory Acceptance Testing (FAT) along with core QA responsibilities.
Key Responsibilities:
- Support preparation and review of qualification documents including DQ IQ OQ and PQ
- Participate in Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) activities
- Ensure compliance with GMP GLP and regulatory requirements (FDA WHO EU)
- Review batch records SOPs and validation documentation
- Handle deviations CAPA and change control processes
- Collaborate with Engineering Production and Vendors for equipment qualification and process improvement
- Ensure traceability across URS DQ FAT SAT and validation lifecycle
- Support audits and regulatory inspections
- Maintain documentation integrity and quality standards
Qualifications :
Required Qualifications:
- Bachelors/Masters in Pharmacy Chemical Engineering Biotechnology or related field
- 37 years of experience in QA within pharmaceutical/biotech manufacturing
- Experience with lyophilization (freeze-drying) systems
- Working knowledge of equipment qualification and validation processes
Key Skills:
- Understanding of validation lifecycle (URS to PQ)
- Exposure to DQ documentation and FAT participation
- Strong knowledge of GMP and quality systems
- Attention to detail and documentation excellence
- Good cross-functional coordination and communication skills
Remote Work :
No
Employment Type :
Full-time
About Company
At Vroutes HR, we focus on creating coaction capabilities and empowering employers with the most precious asset-people. With a combination of innovative technology and personal touch, we have enabled marketing and advertising firms to achieve their vision. Founded in the year 2017 Vro ... View more
