Pharma Quality Assurance Specialist-I at Cepheid
Location: Bangalore, Karnataka, India
Category: Quality & Regulatory Affairs
Job ID: R1251487
This job is available in 2 locations: Bangalore, Karnataka, India and Bengaluru, India
At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.
Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we’re working at the pace of change on diagnostic tools that address the world’s biggest health challenges, driven by knowing that behind every test there is a patient waiting.
Learn about the Danaher Business System which makes everything possible.
- Review records and documents: for completeness and compliance with regulatory requirements and ISO requirements.
- Review Batch Records/Device History Records (DHR): to support the release of raw materials, work in progress, and final products. This includes reagents, components, and instrumentation-related products.
- Collaborate with other function teams: to resolve batch record discrepancies or errors as it relates to Good Documentation Practice.
- Review and assist to improve standard operating procedures/ operation processes: and quality system functions.
- Support the Material Review Board: for the assessment and disposition of non-conforming materials and closure of Non-conformance and Deviation Report, as needed.
- Support PDR closure: as needed.
- Support for internal and external audit for site.
- Preparing and implementing quality assurance policies and procedures.
- Performing routine inspection and quality tests.
- Address and discuss issues and proposed solutions: with cross-functional departments.
- Be proactive in identifying process and knowledge gaps: and effectively manage escalations.
- Identify opportunities for increasing operational efficiencies.
- Display an appreciation of control, quality and risk related issues: Ensure existent controls are followed by the team.
*All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.*
- Complete all assigned and required training satisfactorily and on time.
Education and Experience:
- Master’s degree in science (Biochemistry, Biotechnology, Pharmacy), medical, or technical field and 5+ years’ Quality assurance experience.
- Experience with in Vitro Diagnostics (IVD) and Medical device is very beneficial and highly desirable.
Knowledge and Skills:
- Hands-on Experience on IVD product testing.
- Working Knowledge of current GxP regulations for Invitro Medical Devices and ISO 13485 QMS.
- Must be flexible to work off-shifts and weekends as per production Schedule.
- Schedule orientated (able to consistently maintain schedules and meet timelines).
- Strong interpersonal skills, Effective organization, and Communication skills are essential.
- Good skills in English language.
- Knowledge of Microsoft Word and Excel.
- Strong multi-tasking and attention to detail skills.
- Working knowledge of tools, methods, and concepts of quality assurance.
- Excellent data collection and analysis skill.
- Experience in Validation Process, Non-conformance process, MRB, and CAPA process.
- Experience representing their department during Internal and External Quality system audits.
- Experience in the medical device industry, knowledge of ISO 13485 and MDR, 2017.
- Experience in leading continuous improvement efforts, in both quality systems and products.
- Knowledge of the process of establishing facility QMS certifications.