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QC Manager

3 months ago

Bengaluru, Karnataka, India Cepheid Full time

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.

In this role, you will have the opportunity to:

The Quality Control Manager is responsible for managing the Quality Control personnel and laboratory operations to support the testing and qualification of raw materials and commercial product. You will be responsible for the hiring, training, and development of Quality Control personnel. You will also maintain Quality Control metrics to assess department and product performance. In this role you will be able to learn our Danaher Business system and Product release process. Support quality system compliance efforts including actions to respond to ISO quality system surveillance audits; monitor the effectiveness of corrective and/or preventive action; provides training and training support to quality systems and related regulatory areas; develop and maintains databases to enhance global quality systems communications; and report quality systems metrics to management. This position is part of the Quality Organization and will be in Bengaluru, India. Our mission is to ensure that performed Quality control activities are done by focusing on the quality of the product, the internal and external customer needs, and according to the Quality System, IVDR and ISO regulations. Our vision in Quality is to make sure our product meets testing requirements prior to leaving the site.

ESSENTIAL JOB RESPONSIBILITIES:

Work cross-functionally and consult frequently with Manufacturing, Supply Chain, Engineering, Quality Assurance, and Product Transfer, in addition to other functional groups. Routinely communicate project goals, status, requirements, and deliverables to Quality Management. Ensure maintenance of QC equipment – qualification, calibration, and maintenance. Lead investigations for failures during Quality Control testing. Ensure routine and non-routine analysis of raw materials, in-process, and finished formulations under supervision and according to Standard Operating Procedures (SOPs) and release all materials to meet daily operations 24/7 or as per shift plan. Supervisory or Department Lead experience managing a technical laboratory team in both processes and resources. Experience with real-time PCR and RT-PCR and molecular diagnostic assays Thorough knowledge of cGMP regulations related to Quality Control. Analytical methods and Microbiology testing. Strong problem-solving/troubleshooting skills that can translate to direct guidance of team members through complex issues.

ADDITIONAL RESPONSIBILITY

Support and development and maintenance of the Cepheid Quality System and Regulatory Compliance (QSRC) functions ensuring Cepheid India has continuous compliance with the corporate Quality Policy Responsible to ensure that the final products are released systematically through the quality system batch review process (instrumentation-related products or reworked and assays final products). Identify, communicate and escalate to Executive Management, as required, compliance issues and risks for further comprehensive action. Ensures staff skills are developed and maintained on a continual basis to ensure quality and effective operations.

It would be a plus if you also possess previous experience in:

Quality Control Laboratory Operations Quality System/Manufacturing Operations

NOTE: All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.

TRAINING RESPONSIBILITIES: (REQUIRED)

Complete all assigned and required training satisfactorily and on time

MINIMUM REQUIREMENTS:

Education and Experience:

Master's Degree in Biochemistry, Molecular Biology, Microbiology or related discipline and 12+ years related medical device and laboratory experience or Master's degree in Biochemistry, Molecular Biology, Microbiology or related discipline and 7 years related laboratory experience Experience with in Vitro Diagnostics (IVD) is very beneficial and highly desirable. Proven people leader & a qualify professional with a min of 10-12 years of total experience, having exposure in both QC and QA operations is a must with people managerial skill.

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 if needed. Schedule orientated (able to consistently maintains 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 details skills.

PREFERRED REQUIREMENTS:

Experience in QC/QA Process, Non-conformance process, 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. Cross functional experience with products and manufacturing processes to influence change at all levels within the organization vision and project knowledge desirable.

When you join us, you'll also be joining Danaher's global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you'll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

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We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment.