Research AssociateJobs Opening in Cadila Pharmaceuticals Ltd at Dholka
FEATURED JOBResearch Associate
Cadila Pharmaceuticals Ltd
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Posted: 01 May 26
Job Description
Job description:
Core responsibility related to GLP (Research Quality Assurance (RQA)):
-Maintain internal quality assurance records, processes, and procedures: Assure QA documents are complete and up to date as required by GLP Standards and day-to-day management of QA activities, including documentation.
-Maintain copies of all approved SOPs in use in the test facility;
-Access to the updated copy of master schedule, and periodically review it.
-Maintain copies of the study plan, subsequent study plan amendments, and study schedule for GLP studies.
-Verify that the study plan contains the information required for compliance with the Principles of GLP and are in compliance with in-house SOPs, Sign the final study plan, when applicable.
-Conduct inspections/audits to determine if all studies are conducted in accordance with the Principles of GLP. Participate in risk assessment procedure at the facility and conduct risk based QA audit.
-Perform various types of audits (study, process or facility based) according to in-house SOP, where applicable.
-Ascertains that the study plans and SOPs are available to personnel conducting the study.
-Inspects the critical phases of GLP study at intervals adequate to ensure the integrity of the study, and maintains written records of details of the findings and deviations from the study plan/SOP (if any).
-Prepare & update RQA audit planners for the critical phases and facility based audits.
-Inspect the final reports to confirm that the methods, procedures, and observations are accurately and completely described, and that the reported results accurately and completely reflect the raw data of the studies;
-Conducts test facility inspections of different areas to ensure the test facility's compliance with GLP regulations. These inspections should be conducted to ensure that the test facility is adequate and well maintained and that all equipment is maintained and calibrated/serviced as per GLP requirements.
-Promptly report any inspection results in writing to management and to the Study Director, and to the Principal Investigator(s) and the respective management, when applicable;
-Prepare and sign a statement, to be included with the final report, which specifies types of inspections and their dates, including the phase(s) of the study inspected, and the dates inspection results were reported to management and the Study Director and Principal Investigator(s), if applicable. This statement would also serve to confirm that the final report reflects the raw data.
-Review the SOPs to assess the clarity, procedural accuracy, and compliance with principles of GLP.
-Preparation, maintenance, review and implementation of Standard Operating Procedures (SOPs), In-house Support Documents (ISDs), and Standard Test Procedures (STPs) for various activities and provide SOP training.
-Review the RQA documents and archive them as per in-house SOP.
-Review of SOP deviation and change control.
-Maintain and update training records and archive them periodically as per in-house SOPS
-Prepare & maintain the report for various audits and report the observation to TFM and SD/HOS/author/concerned personnel.
-Conducts training on GLP regulations and their updates for the test facility staff.
-Interact with regulatory personnel for scheduling the inspections and audits of regulatory studies.
-Perform vendor or supplier or service provider audits to qualify them for their supplies or services.
-For a multisite study: If appointed as Lead QA: Liase with test site QA to ensure adequate quality assurance inspection coverage throughout the study. And, if appointed as test site QA: Should fulfil QA responsibility as listed above and responsible for the QA monitoring of phase delegated at test site.
-Inspection of archiving operations and procedures, including procedures for electronic records, facilities, stored records and materials.
-Computerised system: Execute QA role in validation of computerised system (review
of validation protocol, user requirement specification, audit of test script execution and validation raw data & report), review data audit trail, data security and compliance of data integrity principles.
Allied responsibility:
-Receive requests for the issue of controlled documents and issue the controlled documents.
-Preparation, maintenance, and coordination with pre-clinical department scientist for scheduling & organizing SOP/scientific, etc. training.
-Assist in coordinating training events and/or preparing training material. This may include any event/activity in which RQA is responsible.
Any additional responsibility/activity as and when assigned by management which would not arise any conflict of interest.
Job Particulars
Education Any Graduate
Who can apply Freshers
Hiring Process Face to Face Interview
Employment TypeFull Time
Job Id2883338
Job Category Sales and Marketing
Locality Address
State Gujarat
Country India
About Company
Cadila Pharmaceuticals Ltd
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