Quality Control Analyst

Job Description

This position is part of the Quality Organization and will be in India. Reporting directly to the Quality Control lead or site 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. In this role, you will have the opportunity to: 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. 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. 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. Education and Experience: masters degree in Biochemistry, Molecular Biology, Microbiology or related discipline and a minimum of 3+ years related Quality Control experience. 2+ years experience with in Vitro Diagnostics (IVD) is mandate 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. It would be a plus if you also possess previous experience in: 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