Danaher Pharma QC Analyst Vacancy 2021 – Apply Online
Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world-class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental.
Job Title: QC Analyst
Location Bengaluru, Karnataka, India
Category Quality & Regulatory Affairs
Job Id R1181178
GCRF Job Level: T2
GCRF Job Family: Quality and Regulatory Affairs
Eligibility Criteria:
- Master’s degree in science (Pharmacy), medical or technical field
- 3-5 years of experience in the medical devices industry (IVD can be a plus)
Knowledge and skills:
- Excellent verbal and written communication skills
- Knowledge of International Organization for Standardization ISO13485
- Knowledge of International regulations QSR for the USA, CE Directive, and Regulation for India.
- Excellent planning and organizing skill
- Exceptionally strong team player with excellent interpersonal and communication skills
- Able to confidently deal with ambiguous issues and provide input towards suitable actions.
- A quality competent technical person approved as per D&C/ India MDR act if any
Preferred:
- 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 commercial operations processes to influence change at all levels within the organization Visio and Project knowledge desirable.
Job Description:
Reporting directly to the head of India Quality System and Regulatory Compliance (QSRC) manager, 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, 21 CFR 820, ISO 13485, Cepheid corporate quality system requirements.
Job Responsibilties:
- Conducts routine and non-routine analysis of raw materials, in-process and finished formulations under the supervision and according to Standard Operating Procedures (SOPs).
- Coordinate and perform incoming inspection / finished goods release activities
Mechanically inspect product dimensional variables using automated and manual measurement methods and machines. - Identify non-conforming products and initiate associated non-conformance documentation
- Review product inspection history to make future inspection decisions
Establish/create work instructions - Perform moderately complex data gathering and report results utilizing statistical methods as appropriate
- Perform data analysis to identify and independently resolve adverse trends
- Verify conformance to specifications and protocols and report outcomes
- Mark items with details such as grade and acceptance or rejection status
- Competent technical staff for supervision of the Testing/ analysis of diagnostic reagents & kits.
Traning Responsibilties:
Complete all assigned and required training satisfactorily and on time
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