- For Experience Candidate Only.
Position : QC / QA / AR&D / FR&D / Microbiology - Jr. Scientist to Team Leader.
Qualification : M.Sc/M.Pharm/B.Sc/B.Pharm.
Experience : 2 to 8 years in Pharma Industry.
Relevant job profile candidates only allow for interview
Role & Responsibility: QC / AR&D Analyst to Team Leader.
Having knowledge in current GLP requirement
Having adequate knowledge in all analytical instruments like HPLC, UPLC, GC and Dissolution tester etc.
Having technical exposure on testing of in-process and finished product batches such as Assay, Related substances/compounds, Dissolution, Content Uniformity & etc as per Good documentation practices.
Experience in Method validations, Method Verifications and Method Transfer for analytical methods of drug products such as Assay, Related substances/compounds, Dissolution, Content Uniformity and residual solvents by using HPLC, GC and UV-Visible spectrophotometer as per current ICH guidelines and Pharmacopoeia.
Experience in calibration of all analytical instruments like HPLC, UPLC, GC, Dissolution tester, UV-Visible spectrophotometer and etc.
Having adequate knowledge in Preparation and review of analytical method validation/ method verification protocols, Method transfer/Routine/Stability documents for drug products such as Assay, Related compounds, Dissolution, Content Uniformity & residual solvents.
Having adequate knowledge for the review of analytical raw data & trend of stability samples.
Having good communication skills and planning of work.
Ability to work in a multi-task environment.
Ability to produce high quality outputs.
JOB PROFILE FOR QA.
Having knowledge in current GLP requirement
Having adequate knowledge in all analytical instruments like HPLC, UPLC, GC and Dissolution tester etc.
Having technical exposure on testing of in-process and finished product batches such as Assay, Related substances/compounds, Dissolution, Content Uniformity & etc as per Good documentation practices.
Experience in Method validations, Method Verifications and Method Transfer for analytical methods of drug products such as Assay, Related substances/compounds, Dissolution, Content Uniformity and residual solvents by using HPLC, GC and UV-Visible spectrophotometer as per current ICH guidelines and Pharmacopoeia.
Experience in calibration of all analytical instruments like HPLC, UPLC, GC, Dissolution tester, UV-Visible spectrophotometer and etc.
Having adequate knowledge in Preparation and review of analytical method validation/ method verification protocols, Method transfer/Routine/Stability documents for drug products such as Assay, Related compounds, Dissolution, Content Uniformity & residual solvents.
Having adequate knowledge for the review of analytical raw data & trend of stability samples.
Having good communication skills and planning of work.
Ability to work in a multi-task environment.
Ability to produce high quality outputs.
JOB PROFILE FOR QA.
Responsible for Implementation, continuous monitoring and reviewing of Quality management system and obtaining of updated regulatory information and implementation in laboratory.
Responsible for reporting of deviations to management and conducting of management review meetings.
Responsible for conducting of internal audits, handling of customer complaints, investigation and Quality checks.
Responsible for approving of new Quality system procedures and revision of existing procedures as per regulatory requirements, for issuance of Deviation, OOS, OOT, CAPA, & Change control forms and follow up with respective departments.
Non conformity activities timely reporting to customer, Conducting of training on latest regulatory requirements.(SOP training, On job-training & class room training)
Responsible for work allocation & monitoring of regular activities, assuring of analytical results and releasing of COAs for routine samples and stability samples.
Responsible for approving of Validation master plan and Qualification protocols for equipments in the laboratory, reviewing and approving of method transfer protocols and reports and work record
Responsible for approving of analytical method development and method validation protocols and reports, review and approval of all records and protocols pertaining to stability study management.
Overall implementation and monitoring for effectiveness of stability procedure, activation of stability study in LIMS and approving of stability reconciliation.
In absence of duties, the responsibilities are handed over to QA-Manager
JOB PROFILE FOR FR&D
Development of a formulation i.e from Literature survey to exhibit batches, preparing documents like literature reports, pre-product development strategy reports.
Preparation, optimization and implementation of scale-up processes , execution of process evaluation and exhibit batches.
Stability management Bench and lab scale along with preparation of Summary reports and preparation of stage wise Product Development Reports.
Acquainted knowledge in USFDA, & ICH Guidelines.
Preparing MFC (Master Formula Card),BMP (Batch Manufacturing protocol),BMR (Batch Manufacturing Record), Product Specifications (IP-FP), Protocols etc.
Preparation of the SOPs, IQ, OQ & PQ for the equipment in R&D and maintenance of the logbooks.
Acquainted knowledge in QbD concepts like indentifying critical process and
Acquainted knowledge to prepare TTD and components for the development of the product.
JOB PROFILE FOR Microbiology
Responsible for smooth functioning of Microbiology department, work allocation and review of reports through ERP, Preparation ,Performance and Reviewing for all Microbilogical Methods Validation and Method Verification Documents.
Responsible for SOP review for Microbiology related Equipments/Analysis, verifying and Reviewing of all Microbiological Samples Raw data reports, customer compliance of Microbiology .
Responsible for initiating change control for Microbiology related Equipments/Analysis, initiating the deviation for Microbiology related Equipments/ Analysis. if any.
Responsible for Audit compliance preparation, implementing new Microbiology technical requirements.
Responsible for co-ordinating with vendors for IQ,OQ,PQ for new equipment/Instrument installation.
Responsible for monitoring and verifying the documentation, responsible for Environmental Monitoring.
Responsible for Media Growth promotion test, Sub Culture maintenance, maintaining of GLP, GDP in Microbiology Lab.
Responsible for reporting of deviations to management and conducting of management review meetings.
Responsible for conducting of internal audits, handling of customer complaints, investigation and Quality checks.
Responsible for approving of new Quality system procedures and revision of existing procedures as per regulatory requirements, for issuance of Deviation, OOS, OOT, CAPA, & Change control forms and follow up with respective departments.
Non conformity activities timely reporting to customer, Conducting of training on latest regulatory requirements.(SOP training, On job-training & class room training)
Responsible for work allocation & monitoring of regular activities, assuring of analytical results and releasing of COAs for routine samples and stability samples.
Responsible for approving of Validation master plan and Qualification protocols for equipments in the laboratory, reviewing and approving of method transfer protocols and reports and work record
Responsible for approving of analytical method development and method validation protocols and reports, review and approval of all records and protocols pertaining to stability study management.
Overall implementation and monitoring for effectiveness of stability procedure, activation of stability study in LIMS and approving of stability reconciliation.
In absence of duties, the responsibilities are handed over to QA-Manager
JOB PROFILE FOR FR&D
Development of a formulation i.e from Literature survey to exhibit batches, preparing documents like literature reports, pre-product development strategy reports.
Preparation, optimization and implementation of scale-up processes , execution of process evaluation and exhibit batches.
Stability management Bench and lab scale along with preparation of Summary reports and preparation of stage wise Product Development Reports.
Acquainted knowledge in USFDA, & ICH Guidelines.
Preparing MFC (Master Formula Card),BMP (Batch Manufacturing protocol),BMR (Batch Manufacturing Record), Product Specifications (IP-FP), Protocols etc.
Preparation of the SOPs, IQ, OQ & PQ for the equipment in R&D and maintenance of the logbooks.
Acquainted knowledge in QbD concepts like indentifying critical process and
Acquainted knowledge to prepare TTD and components for the development of the product.
JOB PROFILE FOR Microbiology
Responsible for smooth functioning of Microbiology department, work allocation and review of reports through ERP, Preparation ,Performance and Reviewing for all Microbilogical Methods Validation and Method Verification Documents.
Responsible for SOP review for Microbiology related Equipments/Analysis, verifying and Reviewing of all Microbiological Samples Raw data reports, customer compliance of Microbiology .
Responsible for initiating change control for Microbiology related Equipments/Analysis, initiating the deviation for Microbiology related Equipments/ Analysis. if any.
Responsible for Audit compliance preparation, implementing new Microbiology technical requirements.
Responsible for co-ordinating with vendors for IQ,OQ,PQ for new equipment/Instrument installation.
Responsible for monitoring and verifying the documentation, responsible for Environmental Monitoring.
Responsible for Media Growth promotion test, Sub Culture maintenance, maintaining of GLP, GDP in Microbiology Lab.
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