Danaher M Pharma Quality Control Analyst Vacancy – Apply Online
Danaher hiring pharmacy candidates for the post of quality control analyst. QC job opening 2022. Analyst job opening 2022. M Pharmacy job opening 2022. Candidates with master’s degree in pharmacy may apply for the job vacancy at Danaher for the post of Quality Control Analyst. Intrested and eligible candidates may check out all the details on the same below:
Job Title: Quality Control Analyst I
Location Sriperumbudur Taluk, India
Category Quality & Regulatory Affairs
Job Id R1206278
- Master’s degree in Pharmacy, medical or technical field and 4+ years experience with increasing responsibility in the Quality Control area
- 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 in 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 the English language
- Knowledge of Microsoft Word and Excel
- Strong multi-tasking and attention to detail skills.
- Experience working with medical device quality systems in compliance with MDR and ISO 13485
- Able to interpret the quality problems 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 are desirable.
Reporting directly to the head of the India Quality System and Regulatory Compliance (QSRC) manager, the Quality Control Analyst is responsible for managing the day-to-day activities and quality control function at Cepheid India Private Ltd. Ensure compliance with quality control procedures as per MDR 2017, European regulations, ISO 13485, Cepheid corporate quality system requirements.
- Competent technical staff for supervision of the Testing/ analysis of diagnostic reagents & kits.
- Conducts routine and non-routine analysis of raw materials, in-process and finished formulations under the supervision and according to Standard Operating Procedures (SOPs).
- Compiles data for documentation of test procedures and prepares reports.
- Performs and calibration and maintenance of lab equipment.
- Reviews data obtained for compliance to specifications and reports abnormalities.
- Revises and updates SOPs.
- May perform special projects on analytical and instrument problem-solving.
- Ensure that lab cleanliness and safety standards are maintained.
- Train other analysts to perform laboratory procedures and assays.
- Perform inspections of incoming, in-process, and finished products.
- Approves inspections of incoming, in-process, and finished products.
- Participate in internal assessments and audits as required.
- 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.
- Supply quality control data necessary for regulatory submissions.
- 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.
- Monitors internal audit schedule, NC, CAPA for site
- Review production batch records, QC test results, and release products.
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