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| Unison Pharmaceuticals Pvt. Ltd Job Opening For BSc/ MSc/ B.Pharm/ M.Pharm - Quality Control Departments |
1. Quality Control - HPLC
Education
B.Pharma in Any Specialization, B.Sc in Any Specialization
MS/M.Sc(Science) in Any Specialization, M.Pharma in Any Specialization
Work Location: Ahmedabad(Moraiya), gujarat
Experience: 2 - 7 Years
Job Purpose:
The QC analyst performs various scientific analyses to evaluate the quality of raw materials, in-process materials, and finished goods and ensure compliance with established standards. He / She conducts and validates various biological and chemical quality control Assay, RS, Dissolution, CU, BU, Swab etc. He / She compiles, interprets, and documents statistical data from testing processes to either confirm compliance with established quality standards or identify deviations. He / She is also responsible for establishing specifications for conducting various analyses.
Key Accountabilities/ Responsibilities
1. HPLC Operation (Analyst)- Assay
Collect worksheet and sample for analysis as per plan
Check the instrument calibration details
Purging the interior part of the instrument
Take the columns as per worksheet and put in instrument
Initiate solution preparation for analysis as per worksheet which majorly includes; Mobile Phase, Standard and sample
Prepare HPLC sequence for analysis and get it review by reviewer
As per the sequence initiate the analysis and online verify SSC criteria as per worksheet
Post completion of the analysis perform documentation and send to reviewer
Calculate final analysis result as per the standard formula mentioned in worksheet and match the result with worksheet range
2. HPLC Operation (Analyst)- Dissolution
Collect worksheet and sample for analysis as per plan
Check the instrument calibration details
Purging the interior part of the instrument
Take the columns as per worksheet and put in instrument
Initiate dissolution solution preparation for analysis as per worksheet and also prepare dissolution medium
Perform dissolution analysis as per the criteria mentioned in worksheet
Post completion of the analysis perform documentation and send to reviewer
Calculate final analysis result as per the standard formula mentioned in worksheet and match the result with worksheet range
3. HPLC Operation (Analyst)- Others
RM- Assay, RS, IR
In process- Assay by UV and HPLC
PV Sample- Assay by UV and HPLC, Dissolution
FP- Assay, Dissolution, RS, DT, Average weight, hardness, Friability, IR
Cleaning validation
Candidates should also have sound knowledge cGMP documentation and must be familiar with cGMP requirements.
Interested candidates may also email their resume to career@unisonpharmaceuticals.com
2. Opening for Quality Control - GLP
Education
B.Pharma in Any Specialization, B.Sc in Any Specialization
M.Pharma in Any Specialization, MS/M.Sc(Science) in Any Specialization
Experience: 2 - 6 Years
Job Description
Roles and Responsibility
Responsible for handling of instruments like HPLC, Dissolution Test Apparatus, UV Spectro Photometer, Disintegration Apparatus and Other Physico Chemical instruments.
Responsible for perform the Calibration of all Analytical Instruments/Equipment lying at Quality control laboratory.
Responsible to perform Equipment/ Instruments Calibration/ Verification. In-case of OOC results inform to superior immediately and follow respective SOP.
Responsible for maintain the Inventory, log record of HPLC columns as per respective Column management SOP.
Execution of Calibration and Preventive Maintenance of QC instruments as per predefined schedule.
Working Standard, Reference Standard and Chemical/Reagent management.
When require give the support in Analytical document preparation like SOPs , Specification, Method of Analysis , Worksheet , Analytical Method Transfer Protocol and Report.
To follow Good Laboratory Practices (GLP), Good Documentation Practices (GDP) and Safety precautions during routine analytical activities.
Daily/ weekly monitoring of Temperature/ Humidity of QC laboratory.
To ensure availability of current version SOPs, Specifications, MOAs, STPs.
To prepare SOPs, Specifications, MOAs, STPs and other documents.
Responsible for preparation of Analytical documents like Specification, Method of Analysis and Worksheet for Active Raw Material, Inactive Raw Material, Finished Product, Finished Product Strip/blister, Semi Finished Product, Granules, and Packing Material and for working standard qualification.
Preparation and maintenance of Miscellaneous documentation.
Archival and Retrieval of Quality documents.
For all the positions, candidates should also have sound knowledge cGMP documentation and must be familiar with cGMP requirements
Interested candidates may also email their resume to career@unisonpharmaceuticals.com
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