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QC Associate print Print

Company Name: Dr Reddys Labs
Location: Hyderabad
Experience: 2 - 3 year(s)
Annual Salary: INR 350000 - 350000
Disability Accepted: Hearing Impairments (Hard of Hearing), Hearing Impairments (Total Deafness), Intellectual Disabilities, Learning Disabilities, Mental Illness, Speech Impairments, Visual Impairments (Low Vision), Visual Impairments (Total Vision Loss), Developmental Disabilities
Vacancies: 4
Posted by : Fanny Mercy , 36 days ago

Job Description

Industry: Pharmaceuticals
Functional Area: Pharmaceuticals
Job Role : QC Associate
Job Description: Test samples for Commercial and Stability batches
Test the samples as assigned & release the data as per defined timelines – Commercial, Stability & Campaign batches
Ensure that no executional errors occurred against set procedures
Ensure that required reagents, buffers are prepared according to the testing plan and equipments are available for analysis IN ORDER to ensure smooth completion of analysis within turn around time.
Document and report test results
Document the activities contemporaneously
Understand the Good Documentation Practices and compliance to the expectations
Self-check of the document after completion of the analysis whether the document is is error free and all entries given correctly; Correct it prior to the submission if found any error IN ORDER to ensure compliance to the good documentation practices.
Support investigation of failure tests and QMS
Inform the supervisor on risk actions like SSF, OOS,OOT & ATI Immediately and support investigation process with required data and analysis;
Understand & adhere to the QMS systems and closure timelines
Support and execute Laboratory investigations and discrepancy closures;
Support in audits as defined role
IN ORDER to ensure the quality of failure investigation is met the defined standards
Ensure compliance to Good Laboratory Practices
Ensure the lab cleanliness, Sample storage, Chemical labelling, removal of expired material, usage of calibrated equipment, usage of authorized/QA issued documents, Analyst qualifications, document revisions as assigned, training compliance and adherence to quality standards/system
Training new joinees on analytical techniques
IN ORDER to ensure the compliance of GLP
Laboratory Equipment management
Calibrate and maintain the assigned equipment as per defined frequency
Qualify the equipment (IQ/OQ/PQ) in a timely manner, with assistance from vendor, in order to support laboratory efficiency
Rectify problems related to the instruments (like air bubble trapping,flow problem,noise problem,changing of frit.) ; In case of unknown problems, do RCA along with investigator & rectify it.
IN ORDER to ensure the laboratory equipment is maintained as per Good Laboratory Practices and cGMP

Desired Candidate Profile

Key Skills: Hands on experience in HPLC techniques like Size exclusion, Reverse Phase, Ion Exchange chromatography, Peptide mapping analysis (specific to Analytics), Hands on experience in Biochemical analysis like Electrophoresis, ELISA & PCR techniques (specific to Analytics), Working experience in cGMP environment with special emphasis on GDP, Should have good documentation skills, Basic knowledge in protein chemistry, Basic knowledge and hands on exposure to Microbiology techniques (incase of Micro Lab), cell culture techniques (incase of BA Lab), communication skills, performance orientation and team spirit
Qualification: B.E/B.Tech, M.E/M.Tech/Ms, M.Sc
Candidate Profile: MSc/ B. Tech/ M. Tech(Microbiology/Biochemistry/Biotechnology) with minimum 2 years of experience

Disabilities Incompatible with this role:
Leprosy cured person / Acid attack victims / Speech & Language disability / Blood disorders: Hemophilia, Thalassemia, sickle cell disease

Knowledge On:
1.Hands on experience in HPLC techniques like Size exclusion, Reverse Phase, Ion Exchange chromatography, Peptide mapping analysis (specific to Analytics)
2. Hands on experience in Biochemical analysis like Electrophoresis, ELISA & PCR techniques (specific to Analytics)
3. Working experience in cGMP environment with special emphasis on GDP
4. Should have a good documentation skills
5. Basic knowledge in protein chemistry
6. Basic knowledge and hands on exposure to Microbiology techniques (incase of Micro Lab), cell culture techniques (incase of BA Lab)

Behavioral Skills:
1. Good communication and writing skills
2. Performance Orientation
3. Able to work in shifts and understanding the team concepts

Company Profile

Company: Dr Reddys Labs
Company Description: Refer company website

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