Cepheid Biotech Job – Biochem QA Job Opening
Job Id: R1251487
Category: Quality & Regulatory Affairs
Location: Bangalore, Karnataka, India
Company Introduction:
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.
Job Responsibilities:
Review of Records and Documents
- Review records and documents for completeness and compliance with regulatory requirements and ISO requirements.
Batch Record Review
- 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.
Collaboration and Problem-solving
- Collaborate with other functional teams to resolve batch record discrepancies or errors as it relates to Good Documentation Practice.
Improvement of Standard Operating Procedures
- Review and assist in improving standard operating procedures/operation processes and quality system functions.
Material Review Board Support
- Support the Material Review Board for the assessment and disposition of non-conforming materials and closure of Non-conformance and Deviation Report, as needed.
Internal and External Audit Support
- Support internal and external audits for the site.
Quality Assurance Policies and Procedures
- Prepare and implement quality assurance policies and procedures.
Routine Inspection and Quality Tests
- Perform routine inspections and quality tests.
Issue Resolution and Cross-Functional Collaboration
- Address and discuss issues and proposed solutions with cross-functional departments.
Process Improvement and Risk Management
- 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 existing controls are followed by the team.
Training Responsibilities:
- Complete all assigned and required training satisfactorily and on time
Minimum Requirements:
- 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-oriented (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 skills.
Preferred Requirements:
- 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.
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.
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