| Company: | CEPHEID |
|---|---|
| Job Role: | Quality Control Analyst. |
| Experience: | (2-3 years). |
| Vacancy: | 25+ |
| Qualification: | BS Degree in Biochemistry, Molecular Biology, Microbiology or related skills. |
| Salary: | ₹ 6.3 LPA. |
| Location: | Bangalore - Karnataka - India. |
| Join us on Telegram | Click Here |
| Apply Mode: | (Online) |
| Deadline: | Not Mentioned |
Cepheid set the standard for innovation in automated molecular diagnostics more than a decade ago, and we never looked back. The Cepheid Platform continues to innovate and expand its capabilities even after installing the largest molecular platform on the planet. GeneXpert® System has been hailed as a game-changer by healthcare leaders across the globe - enabling institutions of all sizes, from small clinics to high volume laboratories and hospitals, to access the speed and accuracy of molecular diagnostics. A growing menu of Xpert® tests from Cepheid spans healthcare infection management, sexual health, infectious diseases, virology, and oncology. Cepheid was founded with the vision of developing a multi-stage, highly complex method to analyze nucleic acids, such as DNA, in samples such as blood, urine, food, and industrial water. During Cepheid's first phase, the company focused on its Smart Cycler® System, which integrated amplification and detection in a single instrument. Founded in 2000, the company went public in the same year. After the 2001 terrorist attacks, the company's focus temporarily shifted. In collaboration with Northrop Grumman, the GeneXpert System powered the United States Postal Service's biohazard detection system (BDS). Since 2003, the program has produced over 15 million test results with no false positives. Cepheid's biothreat business eventually grew to $58 million at its peak, but the company quickly returned to its vision of providing the GeneXpert System, and associated proprietary tests, to the clinical market. Cepheid is part of the Danaher operating company family today. Through the company's patient-centric approach, it aims to bring the advantages of seamless, accessible molecular testing closer to patients, improving the quality of care, lowering costs, and improving outcomes.
JOB DESCRIPTION
POSITION SUMMARY:
- Reporting directly to the Quality System lead, the Quality Control Analyst is responsible for managing the day today activities quality control function at Cepheid India Private Ltd.
- Ensure compliance of quality control procedures as per MDR 2017, European regulations, ISO 13485, Cepheid corporate quality system requirements.
ESSENTIAL JOB RESPONSIBILITIES:
- Conducts routine and non-routine analysis of raw materials, in-process and finished formulations under supervision and according to Standard Operating Procedures (SOPs).
- Competent technical staff for supervision the Testing/ analysis of diagnostic reagents & kits.
- Perform inspections of incoming, in-process and finished products.
- Compiles data for documentation of test procedures and prepares reports.
- Performs and calibration and maintenance of lab equipment as per requirements.
- May perform special projects on analytical and instrument problem solving.
- Ensure that lab cleanliness and safety standards are maintained.
- Identify and troubleshoot product problems.
- Qualify test methods as part of new product development activities.
- Serve as a technical liaison between quality control and other departments
- Write technical reports or documentation such as deviation reports, testing protocols, and trend analyses.
- Write or revise standard quality control operating procedures.
- Perform validations or transfers of analytical methods in accordance with applicable policies or guidelines.
- Follow documentation procedure (filling out Data History Records (DHRs), reading and understanding instructions from Work Release (WR), Planned Deviation Report (PDR) or Non-Conformance Report (NCR). Read and follow Standard Operating Procedures (SOPs) and Manufacturing Work Instructions.
- Review records and documents for completeness and compliance with company policies and procedures.
- Support for internal audit schedule, NC, CAPA for site.
- Review production batch records, QC test results and release product.
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 a minimum of 3+ years related Quality Control experience.
- Experience with in Vitro Diagnostics (IVD) is very beneficial and highly desirable
- Quality competent technical person approved as per D&C act if any
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 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 working with medical device quality systems in compliance with MDR and ISO 13485
- Able to interpret quality problem and establish practical solutions within a dynamic business environment.
- 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 Visio and Project knowledge desirable.
How to Apply Click on the Below link, it will redirect you to source Page and apply there.
.jpeg)
.jpeg)
No comments:
Post a Comment