Piramal Life Sciences Limited (PLSL) is an independent research-driven drug company that was recently demerged from Piramal Healthcare Limited (Formerly known as Nicholas Piramal India Limited). PLSL was formerly the NCE R&D division of NPIL. PLSL has state-of-the-art R&D laboratories built over 200,000 square-feet of space in Mumbai, India and over 300 scientists engaged in drug discovery and development.
Post: Senior Executive/ Deputy Manager- GLP 001
Job Responsibilities:
* Maintain copies of all approved Study Plans and Standard Operating Procedures in use in the test facility
* Verify and document that the Study Plan and Study Plan Amendments, if any, contains the information required for compliance with the Principles of Good Laboratory Principles (GLP)
* Conduct inspections of all departments in GLP framework to determine if all studies are conducted in accordance with Principles of Good Laboratory Practice
* Inspect general documents such as organograms, job descriptions, curriculum vitae, training records, instrument master list, and their maintenance and calibration records
* Inspect GLP Functional Groups at Piramal to determine whether the test facility is suitable for carrying out studies in compliance with the principles of GLP
* Inspect Test Item Control Office (TICO) to determine whether the records are maintained for test and reference item characterization, date of receipt, expiry date, quantities received and used in studies are maintained
* Conduct inspections of Archives (ARC) to assure secure storage and retrieval of archived materials, such as study plans, raw data, final reports, sample of test items and specimens, etc.
* Inspect to assure that all computerized systems used for the generation, measurement or assessment of data intended for regulatory submission are developed, validated, operated and maintained in ways which are compliant with the GLP principles
* Determine the critical phases of the study in consultation with the Study Director and schedule audits/inspections at appropriate times for quality assurance
* 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
* 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
* Impart training on QAU SOPs and GLP to all personnel in GLP framework at Piramal
* Maintain the record of inflow and outflow of all documents in QAU
* Responsible for writing SOPs for the QAU program, also the SOPs delegated to QAU by TFM at Piramal
* Responsible for archiving of documents pertaining to QAU functions * Involved in assessment of Vendors /Suppliers along with the Functional Group * Review all draft SOPs before introduction/ revision and document it * Performing QA activities for Multi-site studies, wherein Piramal is a test-site * Shall be responsible for facilitating the inspections carried out by GLP monitoring authorities * Conduct inspections as per OECD Principles of GLP
Desired Skills:
* Presentation, Analytical, IT, Time management skills
Any Other Information:
* Good communication (verbal and writing) skills , Aptitude for dealing with repetitive jobs , Team player.
In case you wish to apply to this position, please send us your CV
Applications may be sent to research.recruitment@piramal.com.
The subject line may read 'Application for Senior Executive / Deputy Manager - GLP 001'
Additional Information:
Experience: 1-4 years working in a GLP facility
Location: Gurgaon, Mumbai
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA
Education: B.Pharma, B Sc, MSc, Science graduate (Pharmacy or pure sciences - biology or chemistry) with experience
See All B.Pharm Alerts B.Sc Alerts Pune Alerts
See All Other Jobs in our Database
.png)
